director of patient safety

HCA Houston Healthcare

<div>This position is incentive eligible. 
 
 
<h5 class="jobSectionHeader">Introduction</h5>
Managers thrive with us! HCA Healthcare is one of the nation&rsquo;s leading providers of healthcare services, comprising of over 180 hospitals and about 2,000 sites of care in 21 states and the United Kingdom. We are looking for a Director Patient Safety for our HCA Houston Healthcare Medical Center team where excellence creates excellence.<h5 class="jobSectionHeader">
Benefits</h5>
HCA Houston Healthcare Medical Center, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:<ul><li>
Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.</li><li>
Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.</li><li>
Free counseling services and resources for emotional, physical and financial wellbeing 
</li><li>
401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service) 
</li><li>
Employee Stock Purchase Plan with 10% off HCA Healthcare stock 
</li><li>
Family support through fertility and family building benefits with Progyny and adoption assistance. 
</li><li>
Referral services for child, elder and pet care, home and auto repair, event planning and more 
</li><li>
Consumer discounts through Abenity and Consumer Discounts 
</li><li>
Retirement readiness, rollover assistance services and preferred banking partnerships 
</li><li>
Education assistance (tuition, student loan, certification support, dependent scholarships) 
</li><li>
Colleague recognition program 
</li><li>
Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence) 
</li><li>
Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.</li></ul>
Learn more about Employee Benefits
Note: Eligibility for benefits may vary by location. 
HCA Healthcare has expanded our influence across the healthcare industry by investing $3.5 billion in capital improvements in recent years. Do you want to be an influencer in healthcare? Apply for our Director Patient Safety role today!<h5 class="jobSectionHeader">
Job Summary and Qualifications</h5>
What you will do in the role:<ul><li>
Advance a patient safety program that promotes a culture of safety and the elimination of avoidable harm.</li><li>
Prevent future harm by initiating and overseeing proactive evaluation and redesign of systems to improve care processes (e.g. forcing functions, checklists, error causation thinking, human factors, applied informatics, culture).
</li><li>Support improved outcomes by emphasizing both appropriate behaviors and robust systems that include concise accountability measures and follow-up.
</li><li>Improve consistent delivery of evidence-based care and reduction in preventable harm by focusing on reliability and applying the principles of reliable design.
</li><li>Reduce variation in care delivery. Partner with the Patient Safety Organization to explore identified variations when appropriate.
</li><li>Utilize alerts and best practices (e.g. Sentinel Event Alerts) to perform gap assessments and implement strong actions that will alleviate identified gaps.</li><li>
Effectively report, investigate, and analyze patient safety incidents, medical errors and potential risks in the facility.</li><li>
Facilitate thorough and credible serious event analysis that result in strong sustainable improvement strategies.
</li><li>Facilitate thorough and credible failure mode effect analysis to identify and mitigate unintended adverse patient outcomes and evaluate effectiveness of process changes.
</li><li>Perform Patient Safety Rounds that identify patient safety risks. Empower staff to identify and participate in resolution of patient safety concerns.
</li><li>Coordinate disclosure of serious events to patients and/or families in accordance with organizational policy and regulations. Assure timely reporting of Patient Safety Work Product (PSWP) to the Patient Safety Organization.
</li><li>Actively participate in PSO learning collaboratives. Ensure implementation of best practices, alerts, and updates to drive patient safety improvement.</li></ul>
<h6 class="jobSectionHeader">What qualifications you will need:</h6><ul><li>
(CPPS) Certified Professional in Patient Safety must be obtained within 1 year of employment start date</li><li>
Bachelors Degree in Healthcare related field required Master's Degree preferred.</li><li>
Three to five years healthcare experience in patient safety, risk, and/or quality preferred. Healthcare experience should be recent and within a clinical setting such as Hospital, Ambulatory Surgery Center, etc.</li></ul>
HCA Houston Healthcare Medical Center is a 445+ bed acute care hospital located in the heart of central Houston, adjacent to the Medical Center and Museum District, and provides quality care for the greater Houston area. Established in 1975, our hospital has been serving Houston for more than 40 years. We provide a wide range of medical services, including cardiology, bariatrics, orthopedics, neurology, emergency care and more. Our comprehensive medical specialties are here to offer individualized care to every individual that walks through our doors. We also offer 24/7 emergency services and two intensive care units: surgical intensive care unit (SICU) and medical intensive care unit (MICU). We are an accredited Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Center and an accredited Chest Pain Center with Primary PCI. We are members of HCA Houston Healthcare, the most comprehensive family of hospitals in the region and part of the leading provider of healthcare in the country, HCA Healthcare. Together we are stronger, smarter and more accessible in providing the patient-centered care you need close to home.
HCA Healthcare has been recognized as one of the World&rsquo;s Most Ethical Companies&reg; by the Ethisphere Institute more than ten times. In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for the delivery of charitable care, uninsured discounts, and other uncompensated expenses. 
 
&quot;Bricks and mortar do not make a hospital. People do.&quot;- Dr. Thomas Frist, Sr. 
HCA Healthcare Co-Founder
If you're looking for a leadership opportunity that provides both personal satisfaction and professional growth, apply to join HCA Healthcare as a Director Patient Safety. Unlock your leadership potential with HCA Healthcare.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</div>

Director Patient Safety

HCA HealthONE Swedish

<div>This position is incentive eligible.
 
 
Salary Estimate: $102440.00 - $159827.20 / year 
Learn more about the benefits offered for this job. 
The estimate displayed represents the typical salary range of candidates hired. Factors that may be used to determine your actual salary may include your specific skills, how many years of experience you have and comparison to other employees already in this role. The typical candidate is hired below midpoint of the range.<h5 class="jobSectionHeader">
Introduction</h5>
Managers thrive with us! HCA Healthcare is one of the nation&rsquo;s leading providers of healthcare services, comprising of over 180 hospitals and about 2,000 sites of care in 21 states and the United Kingdom. We are looking for a(an) Director Patient Safety for our HCA HealthONE Swedish team where excellence creates excellence.<h5 class="jobSectionHeader">
Benefits</h5>
HCA HealthONE Swedish, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:<ul><li>
Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.</li><li>
Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.</li><li>
Free counseling services and resources for emotional, physical and financial wellbeing 
</li><li>
401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service) 
</li><li>
Employee Stock Purchase Plan with 10% off HCA Healthcare stock 
</li><li>
Family support through fertility and family building benefits with Progyny and adoption assistance. 
</li><li>
Referral services for child, elder and pet care, home and auto repair, event planning and more 
</li><li>
Consumer discounts through Abenity and Consumer Discounts 
</li><li>
Retirement readiness, rollover assistance services and preferred banking partnerships 
</li><li>
Education assistance (tuition, student loan, certification support, dependent scholarships) 
</li><li>
Colleague recognition program 
</li><li>
Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence) 
</li><li>
Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.</li></ul>
Learn more about Employee Benefits
Note: Eligibility for benefits may vary by location. 
HCA Healthcare has expanded our influence across the healthcare industry by investing $3.5 billion in capital improvements in recent years. Do you want to be an influencer in healthcare?
 Apply for our Director Patient Safety role today!<h5 class="jobSectionHeader">
Job Summary and Qualifications</h5>
I. Position Summary: Advance a patient safety program that promotes a culture of safety and the elimination of avoidable harm.
II. Major Responsibilities:
Systems Thinking and Reliable Design Expectations:
<ul><li>Prevent future harm by initiating and overseeing proactive evaluation and redesign of systems to improve care processes (e.g. forcing functions, checklists, error causation thinking, human factors, applied informatics, culture).
</li><li>Support improved outcomes by emphasizing both appropriate behaviors and robust systems that include concise accountability measures and follow-up.
</li><li>Improve consistent delivery of evidence-based care and reduction in preventable harm by focusing on reliability and applying the principles of reliable design.
</li><li>Reduce variation in care delivery. Partner with the Patient Safety Organization to explore identified variations when appropriate.
</li><li>Utilize alerts and best practices (e.g. Sentinel Event Alerts) to perform gap assessments and implement strong actions that will alleviate identified gaps.
</li></ul>Identification and Mitigation of Patient Safety Risk Expectations:
<ul><li>Effectively report, investigate, and analyze patient safety incidents, medical errors and potential risks in the facility.
</li><li>Facilitate thorough and credible serious event analysis that result in strong sustainable improvement strategies.
</li><li>Facilitate thorough and credible failure mode effect analysis to identify and mitigate unintended adverse patient outcomes and evaluate effectiveness of process changes.
</li><li>Perform Patient Safety Rounds that identify patient safety risks. Empower staff to identify and participate in resolution of patient safety concerns.
</li><li>Coordinate disclosure of serious events to patients and/or families in accordance with organizational policy and regulations.
</li><li>Assure timely reporting of Patient Safety Work Product (PSWP) to the Patient Safety Organization.
</li><li>Actively participate in PSO learning collaboratives. Ensure implementation of best practices, alerts, and updates to drive patient safety improvement.
 </li></ul>Safety Culture Advancement Expectations:<ul><li>Champion completion of Culture of Safety Survey.
</li><li>Facilitate analysis of culture of safety survey results such that data-driven action plans lead to targeted outcomes.
</li><li>Support and encourage harm reporting throughout the organization through a non-punitive just event reporting system.
</li><li>Provide feedback that acknowledges both the value of event reporting and review of reported events.
</li><li>Facilitate thorough and credible review of events that address both system and individual accountability.
 </li></ul>Patient Safety Education Expectations:<ul><li>Include patient safety in new hire orientation presentation (e.g. PSO membership, reporting expectations, safety culture)
</li><li>Provide ongoing education to leaders, clinicians and staff on the science of safety (high reliability, effective communication, sustaining awareness/alertness) and patient safety initiatives.
 </li></ul>Partnership with Executive and Clinical Leaders Expectations:<ul><li>Work with facility leaders and managers to ensure thorough, credible and timely event management.
</li><li>Join with facility leaders to identify and hardwire behavioral norms that promote a culture of safety.
</li><li>Work with facility leaders to ensure understanding of and compliance with the National Patient Safety Goals.
</li><li>Partner with facility leadership to establish activities that enable and sustain an open and fair environment promoting learning, safe systems, and appropriately managing behavioral choices related to patient safety (e.g. Patient Safety Rounds, Event Response, Disclosure).
</li><li>Partner with Quality to complete the NQF Safe Practices section of the Leapfrog Hospital Survey.
 </li></ul>Patient and Family Engagement Expectations:<ul><li>Engage patients/families when appropriate in the patient safety program.
</li><li>Seek input from patients/families involved in harm or close call events as appropriate.
 </li></ul>Measurable Reduction in Avoidable Harm Expectations:<ul><li>Oversee the management and use of event information to benchmark and track progress to zero avoidable harm.
</li><li>Provide analysis and identifying trends from reports (e.g. event data, SHARP report, Service Line Dashboards) to track progress of improvement strategies. Spread and sustain improvement.
</li><li>Present informative and actionable patient safety reports to appropriate committees to include high level presentations to Leadership, Medical Executive Committee and Board of Trustees. Include the patient&rsquo;s story of harm.
</li></ul>Risk Management/Claims Activities (if not otherwise assigned)
<ul><li>Work with defense legal counsel to coordinate the investigation, processing and defense of claims against the facility; records, collects, documents, maintains, and provides to defense attorneys any requested information and documents necessary manage facility claims while maintaining privilege of PSWP
</li><li>Notify and interact with HCI of all actual and potential claims
</li><li>Work with security on procedures to reduce the frequency and/or minimize the severity of property loss or assets
</li><li>Contract Review
</li><li>Manage non-HCI cases: accept/process subpoenas, visitor events, property loss or theft, etc. 
 </li></ul> 
III. Position Requirements:
A. Licensure/Certification/Registration:
<ul><li>Certification in Patient Safety (CPPS) required;
</li></ul>o Maintain CPPS while in role
<ul><li>Other licenses/certifications required by State</li></ul> 
B. Education:
Bachelor&rsquo;s degree in Healthcare related field required. Master&rsquo;s degree preferred. 
C. Experience:
<ul><li>Clinical background preferred
</li><li>Three to five years healthcare experience in patient safety, risk, and/or quality preferred. Healthcare experience should be recent and within a clinical setting such as Hospital, Ambulatory Surgery Center, etc. 
</li></ul> 
D. Knowledge/Skills/Abilities:
<ul><li>Demonstrates good organizational skills; tendency to be organized, planful and structured
</li><li>Knowledge of patient safety science principles, theory, methods, standards and regulatory requirements
</li><li>Superior interpersonal skills (developing and maintaining positive relationships; communicating clearly and effectively with people at all levels with verbal and nonverbal communication; working with others to identify, define and solve problems)
</li><li>Strong leadership qualities (task completion, motivation, organization)
</li><li>Knowledge of and experience with patient safety analysis techniques (methods). Proven team building skills in dealing with intra-professional clinical and operations teams including medical staff in diverse settings
</li><li>Advanced computer skills with word processing and database competency.
</li><li>Excellent oral and written communication skills.
</li><li>Demonstrated ability to deliver educational and informational presentations on clinical and/or patient safety topics.
</li><li>Ability to inspire others to believe in the culture of patient safety. Effective change agent.
</li><li>Information management skills including flowcharting, data analysis and report preparation.
</li><li>Knowledge of rapid cycle improvement theory
</li></ul>HCA HealthONE, one of the largest and most comprehensive healthcare systems in the Rocky Mountain region, offers more than 170 care sites in the Denver metro area. Offering services across the continuum of care to meet patients&rsquo; total healthcare needs, HCA HealthONE includes seven acute care hospitals, a dedicated flagship pediatric hospital, a rehabilitation hospital, CareNow&reg; urgent care clinics, mental health campuses, imaging and surgery centers, physician practices, home and hospice care, and AirLife Denver, which provides regional critical care air and ground transportation. Among HCA HealthONE&rsquo;s acute care hospitals is Swedish, a proud member of the community for more than 115 years. An acute care hospital with 408 licensed beds, HCA HealthONE Swedish is a national leader in neurosciences and serves as the region&rsquo;s preeminent referral center for the most advanced stroke treatment and was the state&rsquo;s first Joint Commission-certified Comprehensive Stroke Center. HCA HealthONE Swedish is also home to a robust robotics program, a certified burn and reconstructive center, and a wide-ranging oncology center. Consistently among the Denver Business Journals&rsquo; list of top corporate philanthropists in the Denver-metro area, HCA HealthONE was named as one of the most community-minded organizations by The Civic 50 and contributed more than $1 million through cash and in-kind donations last year alone, along with more than $400M in federal, state and local taxes.
HCA Healthcare has been recognized as one of the World&rsquo;s Most Ethical Companies&reg; by the Ethisphere Institute more than ten times. In recent years, HCA Healthcare spent an estimated $3.7 billion in costs for the delivery of charitable care, uninsured discounts, and other uncompensated expenses. 
&quot;Bricks and mortar do not make a hospital. People do.&quot;- Dr. Thomas Frist, Sr. 
HCA Healthcare Co-Founder
If you're looking for a leadership opportunity that provides both personal satisfaction and professional growth, apply to join HCA Healthcare as a(an) Director Patient Safety.Unlock your leadership potential with HCA Healthcare.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</div>

Community Health System

<div>Overview:

Opportunities for you!<ul><li>
Consecutively recognized as a top employer by Forbes, and in 2025 by Newsweek</li><li>
We&rsquo;re excited to offer a progressive sign-on incentive and comprehensive relocation package</li><li>
Eligible for annual incentive program</li><li>
Community University leadership training courses</li><li>
Tuition reimbursement, education programs and scholarships</li><li>
Vacation time accrues from Day 1</li><li>
Free money toward retirement with a 403(b) and matching contributions</li><li>
Great food options with on-demand ordering</li><li>
Free parking and electric charging</li></ul> 
Commitment to diversity and inclusion is a cornerstone of our culture at Community. All are welcome as valued members of our community.
We know that our ability to provide the highest level of care is through taking care of our incredible teams. Learn more on our Benefits page. 
<div></div>
Responsibilities:
<div>The Director of Risk Management and Patient Relations directs, manages, and plans all aspects of Risk Management and Patient Relations Programs for Community Health System (CHS). Responsible for administering the Risk Management Program to include managing, and analyzing risk management data, and conducting risk management educational programs. Directs completion of root cause analyses, and risk assessments. Collaborates with Patient Safety on initiatives, and activities that support the Patient Safety Program. Ensures the organization's risk management policies and strategies are compliant with applicable regulations, rating agency standards, and strategic imperatives of CHS. The Director oversees advocacy initiatives, and process management of complaints, grievances, and lost property, including the review, mitigation, resolution, reporting, and compliance requirements within internal and external regulations, and policies throughout CHS.</div><div>
</div><div>
Additionally, the Director supports the Captive Insurance Risk Management program, and works to develop, implement, and maintain risk assessment, and mitigation programs within the organization. Works with facility administration, departments, and the medical staff to monitor and evaluate the safety of patient care services. Responsible for assessing, and improving existing protocols, driving accountability across departments, and leading staff with clarity to enable the organization to fulfill its mission by meeting or exceeding its goals.</div><div>
</div>
Qualifications:
<div>Education</div><ul><li>Bachelor's Degree in a healthcare related field required</li><li>Master's Degree in a healthcare related field preferred</li></ul><div>
</div><div>
Experience</div><ul><li>7 years of experience in the healthcare or informatics field with 3 of the years in a progressive healthcare leadership role required</li><li>Previous employment in a highly confidential position within a Patient Safety, Risk Management or Regulatory Compliance department required</li></ul><div>
</div><div>
Licenses and Certifications</div><ul><li>One of the following is required</li></ul><div>
o RN - Current and valid Registered Nurse license to work within the state of California</div><div>
o CPHQ - Certified Professional Healthcare Quality</div><div>
o CPHRM - Certified Healthcare Risk Management</div>
Disclaimers:
<ul><li>Pay ranges listed are an estimate and subject to change.</li><li>If any bonuses are noted, they are only applicable to external hires meeting criteria.</li></ul></div>

Director, Risk Management - Patient Relations

Parexel

<div>Join our dynamic Patient Safety team as a Senior Physician where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and post-marketing settings. In this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance.<h2 class="jobSectionHeader">
About the Role</h2>
As a Senior Physician in Patient Safety, you'll serve as the medical authority on safety profiles for assigned products, ensuring compliance with global regulations while providing critical medical insights. You'll collaborate with cross-functional teams, interact with clients, and contribute to the continuous improvement of our pharmacovigilance processes.
Key Accountabilities:
General<ul><li>
Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client&rsquo;s guidelines and procedures, and global drug safety regulations and guidelines</li><li>
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting</li><li>
Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee</li><li>
Interacting with internal and external stakeholders for resolving issues</li><li>
Attending and/ or presenting at client/cross functional meetings along with other stakeholders. Working as Subject Matter Experts (SMEs)</li><li>
Assisting the Project Lead/Functional Lead for audits and inspections</li><li>
Provides inputs for process improvements</li><li>
Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process</li><li>
Function as pharmacovigilance representative/safety scientist</li><li>
Attend/support Bid defense meetings</li><li>
Actively mentoring Patient Safety Physicians to develop their skills and expertise</li></ul>
Case report medical review (as applicable)<ul><li>
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client, as require</li></ul><ul><li>
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality</li><li>
Review appropriateness of medical content in narrative for medical coherence</li><li>
Assessing seriousness, listedness / expectedness of reported events.</li><li>
Providing medical inputs to case processing team</li></ul><ul><li>
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)</li><li>
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative</li><li>
Identify and resolve case issues, coordinate with client therapeutic/legal team</li><li>
Provide guidance to junior physicians on case assessment methodologies</li></ul>
Periodic reports (as applicable)<ul><li>
Reviewing and/ or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs</li></ul><ul><li>
Providing medical inputs into, and supporting the preparation of key regulatory documents including but not limited to, Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Signal Evaluation Reports (SERs), Health Authority (HA) response documents, Development Safety Update Reports (DSURs), Clinical Overviews (COs), Addendum to Clinical Overview (ACOs), Health Hazard Evaluation reports (HHEs), etc.</li><li>
Clinical Expert Statements and other documents as required</li><li>
Review reports assessed by junior team members for accuracy and completeness</li></ul>
Medical monitoring (as applicable)<ul><li>
Answering day to day medical and scientific questions, provide daily medical support to Parexel staff or site (investigator/study coordinator), as needed</li><li>
Review and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness; provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authorities</li><li>
Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)</li><li>
Provide medical safety expertise to client per request</li><li>
Review and sign off Data Management line listings (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication, efficacy end points), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities</li><li>
Review and sign off technical documents written by Parexel with respect to medically relevant matters with particular attention to those relating to patient safety</li><li>
Review coding of adverse events, medical history and concomitant medications for accuracy and consistency</li><li>
Review of patient profile report as needed</li><li>
Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors in conjunction with clients/sponsors or in conjunction with other Parexel departments</li><li>
Attend and present material as requested, at internal and external meetings (e.g., investigator meetings, therapeutic area training, Regulatory Authority meetings)</li></ul>
Literature review (as applicable)<ul><li>
Review of literature for product safety assessment and potential safety issues</li><li>
Expert in reviewing literature references including triaging, summarizing and providing MAH comments for aggregate reports and for various signal management activities</li></ul>
CSR Narratives (as applicable)<ul><li>
Performing medical review of Clinical study report narratives according to the client&rsquo;s guidelines and SOPs</li></ul>
Provide medical guidance to PV team/study team<ul><li>
Provide medical guidance to safety staff during the case processing cycle</li><li>
Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs)</li><li>
Provide medical input into Pharmacovigilance workflows and projects as required</li><li>
On an as-needed basis, provide support in mentoring or training of new hired physicians</li></ul>
Signal Detection and Management (as applicable)<ul><li>
Perform signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Perform medical assessment of safety alerts obtained from data mining activities</li><li>
Perform signal validation activities</li><li>
Author/review SERs. Perform case analysis, review literature summaries, check draft for medical and scientific accuracy and cohesiveness</li><li>
Author/review responses to HA requests and other safety documents</li><li>
Providing oversight and relevant inputs to Medical Writers (MWs) authoring SERs, Signal validations etc.</li><li>
Managing safety signals on project specific tools (e.g., Signal Tracking System, Signal management tools, etc.)</li><li>
Contribution to Safety Management Team (SMT) meetings: Data analysis/ review, content creation, presentation/ facilitation, drafting of meeting minutes</li><li>
Training and mentoring junior team members on signal detection methodologies</li></ul>
Brand safety Physicians (as applicable)<ul><li>
Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues</li><li>
Support the preparation and maintenance of Risk Management Plans</li><li>
Prepare and review periodic safety reports (PBRER/PSUR, DSUR, European union renewal, HHE and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs</li><li>
Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels and Development Core Safety Information (DSCI)</li><li>
Coordinate safety activities between Drug Safety Unit/team and internal and external partners</li><li>
Conduct/support signal detection and evaluation according to SOPs and guidelines</li><li>
Prepare safety assessments, SERs, as necessary, for potential signals or issues (product quality)</li><li>
Perform review and summarization of literature citations including epidemiology background research</li><li>
Provide safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents</li><li>
Contribute to regulatory agency submissions (Investigational new drug applications, new drug applications, Marketing authorization applications, Variations and Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages</li><li>
Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable</li></ul>
Therapeutic Area Expert (as applicable)<ul><li>
Serve as a subject matter expert within the designated Therapeutic Area, providing specialized knowledge to support drug safety initiatives and decision-making processes</li><li>
Collaborate with the TA Lead to implement strategic plans and enhance the overall expertise within the Therapeutic Area</li><li>
Contribute to the development and delivery of targeted training programs, elevating the knowledge base of fellow physicians and cross-functional teams</li><li>
Actively participate in internal and external scientific forums, representing Parexel's medical expertise through presentations, publications, and thought leadership activities</li><li>
Apply deep therapeutic knowledge to optimize pharmacovigilance processes, ensuring best practices are followed and continuously improved</li><li>
Mentor junior physicians within the TA, fostering their professional growth and encouraging their contributions to the field</li><li>
Support the TA Lead in identifying emerging trends and potential opportunities for innovation within the Therapeutic Area</li><li>
Engage in cross-functional projects, offering expert guidance to enhance the quality and efficiency of drug safety assessments</li></ul>
Skills:<ul><li>
Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date</li><li>
Demonstrated success in technical proficiency and scientific creativity</li><li>
Ability to work on complex tasks requiring in-depth evaluation</li><li>
Good knowledge of drug safety and the drug development process</li><li>
Ability to exercise judgment within broadly defined practices and policies</li><li>
Good presentation and verbal/written communication skills</li><li>
Good interpersonal skills</li><li>
Client focused approach to work</li><li>
Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps</li><li>
An ability to comprehend various regulatory or client requests and be able to strategize a handling approach</li><li>
Experience mentoring junior team members</li><li>
A flexible attitude with respect to work assignments and new learnings</li><li>
An ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail</li><li>
An ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential</li><li>
A willingness to work in a matrix environment and to value the importance of teamwork</li><li>
Strong knowledge of international drug regulation including ICH GCP, GVP, and all other applicable regulations and guidelines</li></ul>
Knowledge and Experience:<ul><li>
US Board Certification/board eligibility or regional equivalent for Canada</li><li>
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required.</li><li>
Previous CRO experience is highly desirable, but individuals with relevant experience as a Patient Safety/Drug Safety Physician within Industry will also be considered.</li><li>
Good knowledge/understanding of medical terminology</li><li>
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice</li></ul>
Education:<ul><li>
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School</li><li>
Completion of at least basic training in clinical medicine (residency, internship etc.)</li></ul>
This role offers the flexibility to work from home in either the US or Canada.
#LI-KS1 
#LI-REMOTE</div>

Senior Physician, Patient Safety (Senior Drug Safety Physician)

University of Florida

<div><div>JOB NO:
<div>539138</div> 
WORK TYPE:
<div>Staff Full-Time</div> 
LOCATION:
<div>Main Campus (Gainesville, FL)</div> 
CATEGORIES:
<div>Health Care Administration/Support</div> 
DEPARTMENT:<div>
29013100 - MD-QUALITY &amp; PATIENT SAFETY</div></div> 
<div>
<div><div><div><div>CLASSIFICATION TITLE:</div>
<div>
Data Scientist IV</div> 
</div> 
<div><div>JOB DESCRIPTION:</div>
<div>
The Data Scientist IV serves as a senior decision scientist within the UF College of Medicine&rsquo;s Quality and Patient Safety initiative (QPSi), providing expert-level leadership in the design and execution of advanced analytic strategies that inform the safe and effective deployment of AI-enabled interventions in clinical workflows.

The incumbent brings deep proficiency in statistical theory, causal inference, and probabilistic modeling, and works with interdisciplinary clinical, operational, and informatics teams to develop rigorous statistical analysis plans and decision-analytic frameworks for complex clinical questions relevant to quality improvement and patient safety.

This role serves as a critical bridge between AI technology investments and measurable clinical impact, ensuring that predictive models and AI-enabled tools are deployed safely, monitored rigorously, and evaluated for their effect on patient outcomes &mdash; directly advancing QPSi&rsquo;s mission to eliminate preventable harm by integrating innovative AI tools with expert care.

About This Role:
<ul>
<li>Leads the development of decision-science and statistical strategies that inform the safe and effective deployment of AI-enabled interventions in clinical workflows. Provides advanced consultation to interdisciplinary clinical, operational, and informatics teams to define decision questions, endpoints, and evaluation approaches. Develops and reviews statistical analysis plans for intervention evaluation, including the application of causal inference methods to estimate impact on clinician behavior, care processes, and patient outcomes under real-world conditions. Produces and validates analytic outputs (tables, figures, and decision summaries) that communicate results and uncertainty to stakeholders and leadership. Analytic outputs directly inform health system leadership decisions on AI deployment scope, expansion, and discontinuation.</li>
<li>Designs and executes simulation-based evaluations to anticipate workflow effects and operational consequences of AI interventions prior to and after implementation. Applies Bayesian statistical modeling and probabilistic reasoning to quantify uncertainty and evaluate candidate intervention strategies in light of clinical and operational tradeoffs (e.g., benefit, burden, timeliness, and resource constraints). Where appropriate, evaluates sequential decision strategies - including reinforcement-learning-informed policy comparisons - in a controlled and reviewable manner to support decisions such as alert thresholds, routing, timing, and escalation pathways. Summarizes scenario-testing results into clear recommendations for implementation teams and governance stakeholders.</li>
<li>Creates and validates analysis datasets and/or reviews those developed by others to ensure data quality, appropriate methods, and accurate calculation of variables from heterogeneous clinical data sources. Develops well-documented, reproducible code and technical documentation to support meetings, presentations, and manuscripts. Contributes to AI governance activities by supporting pre-deployment analytic review, defining monitoring metrics, and performing postimplementation impact evaluation, including periodic performance assessment and interpretability/quality checks as required by program needs.</li>
</ul>
About COM's Quality and Patient Safety Initiative (QPSi):

The UF College of Medicine's Quality and Patient Safety Initiative (QPSi) is dedicated to enhancing patient care quality and safety through innovative research, education, and collaboration. This initiative focuses on implementing evidence-based practices, advancing patient safety initiatives, and fostering a culture of continuous improvement within the College of Medicine.

QPSi's mission is to drive excellence in healthcare delivery by integrating clinical expertise, data-driven insights, and cutting-edge technology. The initiative engages healthcare professionals, students, and stakeholders in efforts to elevate patient care standards and outcomes.

For more information about the Quality and Patient Safety Initiative, visit UF College of Medicine's QPSi.

We Offer Exceptional Benefits:
<ul>
<li>Low-cost State Health Plans: Medical, Dental, and Vision Insurance</li>
<li>Life and Disability Insurance</li>
<li>Generous Retirement Options to secure your future</li>
<li>Comprehensive Paid Time Off Packages: (includes over 10 paid holidays, as well as paid family, sick and vacation leave)</li>
<li>Exceptional Personal and Professional Development Opportunities: Access to UF Training &amp; Organizational Development programs, leadership development, LinkedIn Learning, and more</li>
<li>Tuition Assistance through the UF Employee Education Program</li>
<li>Public Service Loan Forgiveness (PSLF) Eligible Employer</li></ul> 
<div>
</div></div></div> 
<div><div>EXPECTED SALARY:</div>
<div>
$115,000 - 125,000 annually</div> 
</div> 
<div><div>REQUIRED QUALIFICATIONS:</div>
<div>
A Bachelor&rsquo;s Degree in data science, statistics, bioinformatics, analytics, or similar field and seven years of experience; Master&rsquo;s Degree in data science, statistics, bioinformatics, analytics, or similar field and five years of experience; Doctoral Degree in data science, statistics, bioinformatics, analytics, or similar field and three years of experience.</div> 
</div> 
<div><div>PREFERRED:</div>
<div>
The ideal candidate will possess:
<ul>
<li>Demonstrated proficiency in R and/or Python for statistical analysis, simulation, and reproducible research.</li>
<li>Deep proficiency in Bayesian statistical modeling frameworks (e.g., Stan, PyMC, JAGS), including understanding of sampler diagnostics, convergence properties, and prior specification.</li>
<li>Strong foundation in causal inference methods (e.g., difference-in-differences, interrupted time series, propensity-based approaches), including the ability to formally state identifying assumptions and assess their plausibility in applied settings.</li>
<li>Demonstrated experience designing and validating simulation models (e.g., Monte Carlo, agent-based, discrete-event) to evaluate interventions or operational scenarios under uncertainty.</li>
<li>Experience working with electronic health record data or large-scale clinical datasets.</li>
<li>Working knowledge of clinical quality improvement, patient safety, or health system operations.</li>
<li>Solid understanding of AI/ML model evaluation, including calibration assessment, performance monitoring, and validation methodology in applied clinical settings.</li>
<li>Experience with AI governance concepts, including pre-deployment review and post-implementation evaluation.</li>
<li>Ability to translate complex analytic findings into clear recommendations for clinical and operational stakeholders who may not have a quantitative background..</li>
</ul>
</div></div> 
<div><div>SPECIAL INSTRUCTIONS TO APPLICANTS:</div>
<div>
In order to be considered, you must upload your cover letter, resume, and contact information for three professional references.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.</div> 
</div> 
<div><div>HEALTH ASSESSMENT REQUIRED:</div> <div>No</div></div></div> 
</div>
</div><div>ADVERTISED:
<div>16 Mar 2026</div> Eastern Daylight Time 
APPLICATIONS CLOSE:
<div><div>30 Mar 2026</div></div>
Eastern Daylight Time</div></div>

Data Scientist IV - Quality and Patient Safety initiatives

Children's Hospital Los Angeles (CHLA)

<div>
 
 NATIONAL LEADERS IN PEDIATRIC CARE
 
 
 
 Ranked among the top 10 pediatric hospitals in the nation, Children&rsquo;s Hospital Los Angeles (CHLA) provides the best care for kids in California.
 
 
 Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children.
 
 
 The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation.
 
 
 Join a hospital where the work you do will matter&mdash;to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding.
 
 
 
 It&rsquo;s Work That Matters.
 
 
 
 
 Overview
 
 
 
 
 Schedule:
 
 Day shift/Hybrid. 3 days on campus, up to two days remote per week as job allows.
 
 
 Monday-Friday
 
 
 
 Purpose Statement/Position Summary:
 
 The RN Patient Safety Coordinator II is responsible for coordinating patient safety program activities including reviewing and managing safety event investigations, risk assessments, and follow-up. Manages and configures event reporting system to support patient safety activities while maintaining the privileges and protections outlined by the Patient Safety and Quality Improvement Act. Fosters an organizational culture of safety through recognition, education, and continuous improvement activities.
 
 
 
 Minimum Qualifications/Work Experience:
 
 2+ years of recent clinical experience in an acute care setting. 2+ years of recent pediatric clinical experience preferred. One year of patient safety, quality improvement or risk management preferred.
 
 
 
 Education/Licensure/Certification:
 
 Bachelor&rsquo;s degree in nursing or other healthcare related field. Master&rsquo;s Preferred. Current active licensure as Registered Nurse.
 
 
 
 Pay Scale Information
 
 
 
 $99,008.00-$169,728.00
 
 
 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate&rsquo;s starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures.
 
 
 Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you&rsquo;ll find an environment that&rsquo;s alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures &ndash; for our patients, as well as for you and your career!
 
 
 CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932.
 
 
 At Children&rsquo;s Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance.
 
 
 Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process.
 
 
 Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA.
 
 
 Patient Safety
</div>

Coordinator II, Patient Safety RN / Patient Safety / Full-time / Days

University of Maryland Medical System

<div>Job Requirements 
 
Provides organizational leadership and subject matter expertise in quality, safety, and regulatory affairs across all Shore Regional Health entities. Leads efforts to maintain continuous regulatory readiness and compliance with applicable accrediting and regulatory organizations. Collaborates with internal and system-wide partners to ensure alignment with UMMS quality, safety, and regulatory standards. Oversees quality reporting and data integrity to support performance improvement and patient safety. Identifies data-driven opportunities for improvement and partners with leaders to implement effective solutions. 
Primary Responsibilities<ul><li>Develop, implement, and lead organization‑wide regulatory, quality, and patient safety programs to ensure continuous compliance with accreditation standards, Medicare and Medicaid Conditions of Participation and Coverage, and State of Maryland regulatory requirements.</li><li>Serve as the primary organizational liaison to accrediting and regulatory agencies, managing official communication, survey readiness activities, corrective action plans, and regulatory inquiries to ensure timely and accurate responses.</li><li>Lead accreditation and survey readiness efforts, including tracer activities, mock surveys, survey coordination, issue clarification, and development of action plans in collaboration with departmental and physician leaders.</li><li>Oversee quality reporting and performance improvement activities, ensuring data integrity, regulatory compliance, and identification of data‑driven opportunities for clinical and operational improvement.</li><li>Provide subject matter expertise and education to leaders, physicians, and staff on regulatory standards, quality improvement methodologies, patient safety practices, and high reliability principles.</li><li>Evaluate, design, and continuously improve the Quality Improvement and Patient Safety Programs in alignment with national trends, best practices, and evolving regulatory expectations.</li><li>Lead patient safety initiatives, including facilitation of Root Cause Analyses and Failure Mode and Effects Analyses, and oversight of patient safety and quality improvement committees.</li><li>Partner with system and organizational stakeholders, including transformation and performance improvement teams, to support change management, high reliability organizing, and sustainable improvement.</li><li>Provide day-to-day leadership and oversight of quality, safety, and regulatory functions, including direct supervision of quality team members, Patient Safety Coordinator, Infection Prevention, and Clinical Informatics Analyst; establish departmental goals, manage performance, and foster a culture of learning and accountability.</li><li>Oversee policy management and governance processes, ensuring organizational policies are current, compliant, and effectively implemented in partnership with process owners.</li><li>Provide administrative and operational leadership for quality, safety, and regulatory teams, including staff development, goal setting, budget management, and fostering a culture of accountability, learning, and continuous improvement.</li><li>Perform all other duties as assigned.</li></ul> 
Work Experience 
 
Education &amp; Experience - Required<ul><li>Master&rsquo;s degree in health care or business-related field
</li><li>Five years health care experience in a clinical discipline, including at least three years quality, safety, and regulatory affairs experience and/or operations leadership experience (or equivalent)</li></ul> 
Education &amp; Experience - Preferred<ul><li>State of Maryland clinical licensure</li><li>CPHQ and CPPS certification</li></ul>
Knowledge, Skills, &amp; Abilities<ul><li>Knowledge of accreditation standards, Medicare Conditions of Participation, patient safety science, and State licensure regulations.</li><li>Advanced oral and written communication skills; demonstrated skill in collaborating effectively with team members, peers, and executive management</li><li>Ability to challenge and debate issues of importance to the organization, including looking at situations from different viewpoints</li><li>Advanced knowledge of applicable regulatory and accreditation standards, requirements, and issues in health care.</li><li>Ability to effectively delegate responsibilities</li><li>Skill in using a variety of operations performance improvement techniques such as Lean and Six Sigma.</li><li>Experience and advanced skill in facilitating groups</li><li>Strong skills in data analysis and display</li><li>Project management and problem-solving skills</li></ul></div>

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