Qureos Mentor

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.
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Senior Physician, Patient Safety (Senior Drug Safety Physician)

<div>Job Summary:
We are looking for a self-directed professional to support clinical data management efforts for the biomeasures endpoints projects. This individual will be responsible for acquiring, processing, and reviewing patient data and records, organizing clinical data forms, implementing data management plans including data preparation and validation activities and define ways to improve operational processes for these activities. They will act independently and in collaboration with study teams seeking to develop and validate novel digital endpoints across different therapeutic areas.
In close partnership with colleagues from Research teams from Research and Development, They will play a key role in the deployment of novel digital endpoints into clinical studies, collection, management and analysis of sensor data, both in patients and healthy volunteers. This role will be central to the deployment and scaling of digital solutions into clinical trials where these technologies may be utilized as efficacy endpoints and provide value to key stakeholders including patients, physicians, payers.
Key Responsibilities:<ul><li>
Data Management POC for studies in which we are included in</li><li>
Responsible for mapping local study dictionaries to CDISC Standards</li><li>
Participate and contribute to the development of operational plans to ensure data quality and completeness</li><li>
Develop, Implement, and Conduct data quality checks as needed for work/studies</li><li>
Work closely with the various stakeholders to understand evolving project portfolio needs, and integration into the systems and requirements; supporting studies with a wide range of disease domains</li><li>
Contribute technical expertise toward the design, implementation, and scaling up of sensor systems and analytics</li><li>
As a medical informaticist, ensure collection, organization, curation, storage and safeguarding of patient data from lab, asset teams, and external collaboration studies is consistent with 21CFR part 11</li><li>
Contribute to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements</li><li>
Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality</li><li>
Manage own time to meet agreed targets</li><li>
Work under general supervision. Performs assignments using established procedures and general instruction</li><li>
Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.</li></ul>
Minimum Requirements:<ul><li>
Master's degree in Health Informatics, Computer Science, Information Systems, or similar field required</li><li>
A minimum of 5+ years of technical experience required, including:</li><li>
Python</li><li>
Unix/Linux environments</li><li>
Version control systems (ex. Git)</li><li>
AWS or other cloud-based development</li><li>
Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave</li><li>
Familiarity with pharmaceutical informatics standards like CDISC and MedDRA</li><li>
GCP experience</li><li>
Strong interpersonal and collaboration skills</li><li>
Demonstrate the ability to build consensus and be agile to changing circumstances and priorities</li><li>
Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data collection, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements</li></ul>
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Clinical Data Manager, Digital Medicine and Translational Imaging - FSP - East Coast US

<div><div>Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and &ldquo;first in human&rdquo; trials are the first step in testing these novel treatments in humans.</div><div><div><div><div><div><div><div><div> 
At Parexel Baltimore Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Then monitor the volunteer participants health status around the clock as per the trial protocol to ensure their safety and wellbeing.
Develop professionally by gaining experience in delivering high-quality research projects in this growing sector.
What you&rsquo;ll do after training is completed (including but not limited):<ul><li>
Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the Early Phase Clinical Unit (EPCU).</li><li>
Assume responsibility for patient care and study conduct assignments.</li><li>
Ensure that all study laboratory and medical tests are completed, and that eligibility requirements specific to the assigned study are met. Assess compliance, symptoms, etc. per study protocol. Arrange for pre/post procedure laboratory work to be performed.</li><li>
Ensure that all established timelines relating to areas of responsibility and assigned projects are met.</li><li>
Participate and may direct identification and enrollment of study participants. Contributes to the development and implementation of study/research objectives.</li><li>
Assess, monitor, record, and report patient&rsquo;s condition and reaction to drugs and treatments to the appropriate physician.</li><li>
Collect and prepare data. Organize and enter data into case report forms.</li><li>
Enter data into databases when required. Assist physicians in completing flow sheets in medical records and progress notes. Update and maintain the contents of the Clinical Study File.</li><li>
Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation.</li><li>
Act as participant advocate in the conduct of clinical studies.</li></ul>
Qualifications<ul><li>
At least 2 years working in a hospital or clinical setting</li><li>
BSN preferred or relevant work experience.</li><li>
Active Registered Nurse License in the state of Maryland</li><li>
Current Basic Life Support (BLS) certification.</li><li>
ACLS certification required within 6 months of start date</li></ul>
Base Pay Range: $40.00 to $46.00 per hour
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.
In addition to base salary, some roles may be eligible for participation in Parexel&rsquo;s annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.
Parexel is dedicated to supporting, developing and retaining a diverse workforce, inclusive of veteran and military spouse talent. The skills and values you have developed are transferrable to meaningful careers here at Parexel. The following military career roles align with this position 66G, 66H, 68C, 4NOX1, 46NX, 66S, 66T, 290X.</div></div></div></div></div></div></div></div></div>

Clinical Research Nurse (Per Diem/PRN)

<div><div>Parexel is in the business of improving the world&rsquo;s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment &amp; Accountability.</div><div>
Parexel is looking for a Medical Director with a very strong background in Ophthalmology to join our Global Medical Sciences team. 
The role can be remotely based in any European country.
The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.
Primary activities will focus on Medical Monitoring Delivery &amp; PV Support. The medical monitor will independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician).
Medical Expertise and experience in Ophthalmology is essential to the medical monitor role and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration on internal therapeutic area meetings, training module development, white papers, slide sets, publications etc.
Client Relationship Building &amp; Engagement, including soliciting and addressing client feedback and suggestions regarding medical study-related activities, are core skills required of the medical monitor.
Business Development: the medical monitor will provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings.
Skills<ul><li>
Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts</li><li>
Client-focused approach to work</li><li>
Excellent time management skills</li><li>
Excellent verbal and written medical communication skills</li><li>
Excellent standard of written and spoken English</li><li>
A flexible attitude with respect to work assignments and new learning</li><li>
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail</li><li>
Willingness to work in a matrix environment and to value the importance of teamwork.</li></ul>
Knowledge And Experience<ul><li>
Experience in clinical medicine (general or specialist qualifications) with Fellowship or specialty training in Ophthalmology, which is expected to be kept up to date.</li><li>
A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred</li><li>
Clinical practice experience</li><li>
Good knowledge of the drug development process including drug safety, preferred</li><li>
Experience in Pharmaceutical Medicine, preferred</li><li>
Experience leading, mentoring and managing individuals/ a team, preferred</li></ul>
Education<ul><li>
Experience as an Ophthalmology Physician in Industry or as a clinical trial investigator is required</li><li>
Previous CRO experience is strongly preferred</li><li>
Medically qualified in an acknowledged medical school with completion of at least basic training in clinical medicine (residency, internship)</li></ul>
The ability to travel 15% domestically or internationally is required.</div> 
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Medical Director - Ophthalmology

Join Parexel and explore 4   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Parexel

About Company

Senior Physician, Patient Safety (Senior Drug Safety Physician)

Clinical Data Manager, Digital Medicine and Translational Imaging - FSP - East Coast US

Clinical Research Nurse (Per Diem/PRN)

Medical Director - Ophthalmology