pharmacovigilance specialist

Accenture

Skill required: Pharmacovigilance Operations - Pharmacovigilance &amp; Drug Safety Surveillance 
Designation: Pharmacovigilance Services Specialist 
Qualifications:MBBS
 
Years of Experience:7 to 11 years
 
About Accenture 
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song&mdash; all powered by the world&rsquo;s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
 
What would you do? You will be aligned with our Life Sciences R&amp;D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance &amp; Regulatory, helping the world&acirc;&euro;&trade;s leading biopharma companies bring their vision to life &acirc;&euro;&ldquo; enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. 
What are we looking for? Looking for a Medical Review Scientist
 
Roles and Responsibilities: &bull;In this role you are required to do analysis and solving of moderately complex problems &bull; May create new solutions, leveraging and, where needed, adapting existing methods and procedures &bull; The person would require understanding of the strategic direction set by senior management as it relates to team goals &bull; Primary upward interaction is with direct supervisor &bull; May interact with peers and/or management levels at a client and/or within Accenture &bull; Guidance would be provided when determining methods and procedures on new assignments &bull; Decisions made by you will often impact the team in which they reside &bull; Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture &bull; Please note that this role may require you to work in rotational shifts
 
MBBS

Pharmacovigilance Services Specialist

Eikon Therapeutics

<div><div>Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.</div>
Position

As the Medical Director, Pharmacovigilance, you will play a pivotal role in ensuring the safety and efficacy of our pharmaceutical products and clinical trials. Operating in a dynamic and collaborative environment, you will provide strategic leadership and oversight to pharmacovigilance activities, contributing significantly to the successful execution of our research and development initiatives.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth &amp; collaboration.

About You
The ideal candidate for this role is an experienced pharmacovigilance leader with exceptional leadership and team management skills. They possess a deep understanding of pharmacovigilance regulations and processes, ensuring that safety reporting and risk mitigation activities are executed with precision and compliance. Their strong organizational and communication skills, along with meticulous attention to detail and analytical abilities, enable them to maintain high-quality standards, oversee vendor relationships, provide education to internal teams, and uphold comprehensive documentation while staying updated on evolving regulations and standards. Their proficiency in pharmacovigilance tools and software, coupled with their ability to collaborate with cross-functional teams, ensures that pharmacovigilance activities align with project goals and timelines.

What You'll Do
<ul>
<li>Pharmacovigilance Leadership: Provide strategic leadership and oversee all aspects of pharmacovigilance activities, including the collection, assessment, and reporting of adverse events associated with our products.</li>
<li>Safety Reporting: Ensure timely and accurate reporting of adverse events to regulatory authorities in compliance with global pharmacovigilance regulations.</li>
<li>ICSR Management: Proficient in case processing, quality checks (QC), medical review and medical approval of adverse event cases, including SAEs, AESI, SUSAR reports.</li>
<li>Signal Detection (in collaboration with the Clinical Safety team): Utilize pharmacovigilance data to identify potential safety signals, assess risks, and contribute to the development of risk mitigation strategies.</li>
<li>Quality Assurance: Maintain high standards of quality and compliance in pharmacovigilance activities, including adherence to internal processes and standard operating procedures.</li>
<li>Vendor Management: Collaborate with external vendors and partners involved in pharmacovigilance activities, ensuring effective communication and oversight.</li>
<li>Training and Education: Provide pharmacovigilance training and education to internal teams and stakeholders to promote a culture of safety.</li>
<li>Documentation: Maintain accurate and comprehensive pharmacovigilance records and documentation.</li>
<li>Regulatory Compliance: Stay informed about evolving pharmacovigilance regulations and industry standards, ensuring ongoing compliance.</li>
<li>Cross-functional Collaboration: Collaborate closely with cross-functional teams, including clinical teams, regulatory affairs professionals, and other stakeholders to align pharmacovigilance activities with project goals and timelines.</li>
</ul>
Qualifications
<ul>
<li>MD and a minimum of 7+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations and processes.</li>
<li>Managerial experience required.</li>
<li>Exceptional leadership and team management skills.</li>
<li>Excellent organizational and communication skills.</li>
<li>Strong attention to detail and analytical abilities.</li>
<li>Proficiency in pharmacovigilance databases and software.</li>
<li>Capability to thrive in a fast-paced and collaborative work environment.</li>
<li>Knowledge of clinical research, regulatory requirements, and biotechnology is advantageous but not required.</li> 
</ul>
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
<ul><li>401k plan with company matching
</li><li>Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
</li><li>Mental health and wellness benefits
</li><li>Weeklong summer and winter holiday shutdowns
</li><li>Generous paid time off and holiday policies
</li><li>Life/AD&amp;D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&amp;D policies
</li><li>Enhanced parental leave benefit
</li><li>Daily subsidized lunch program when on-site
</li></ul>The expected salary range for this role is $239,000 to $261,250 depending on skills, competency, and the market demand for your expertise.<div>
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.</div></div>

Medical Director, Pharmacovigilance

Deciphera Pharmaceuticals

<div>
 
 Job Description
 
 
 
 The Pharmacovigilance Scientist serves an integral role in safety data analyses for assigned investigational and/or marketed product(s) in partnership with the Safety Physician. The Pharmacovigilance Scientist is expected to be equally effective working collaboratively and independently. She/he will support activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and other safety analyses; and must ensure deliverables are of high quality and are completed according to required timelines. For investigational products, this role will contribute to safety review and analysis for clinical trial documents. The Pharmacovigilance Scientist will also support the maintenance of relevant SOPs, Work Instructions, and other documents.
 
 
 The successful candidate will have demonstrated adequate prior experience of the above responsibilities. Key indicators of success in this role include accountability, attention to detail, appropriate prioritization, management of assigned projects with quality and timeliness, and effective communication.
 
 
 This position will report to the Sr. Pharmacovigilance Scientist and will be located in the Waltham, MA office/Remote.
 
 
 
 What You&rsquo;ll Do
 
 
 
 <ul>
 <li>
 Coordinate and document signal management activities with the product Safety Physician. This includes performing signal evaluations and drafting signal evaluation reports.
 </li>
 <li>
 Prepare aggregate safety reports (e.g. DSURs, PADERs, PBRERs), including project management, database requests, data analysis, report authoring, assimilating information from other groups, review coordination, and quality checks.
 </li>
 <li>
 Support RMP updates and REMS reports as appropriate.
 </li>
 <li>
 Perform literature surveillance for marketed and investigational products .
 </li>
 <li>
 Prepare materials for Safety Committee meetings in conjunction with the product Safety Physician and document/archive meeting minutes and materials.
 </li>
 <li>
 Coordinate responses for ad hoc safety queries in conjunction with the Safety Physician and other cross-functional experts, including data analysis and authoring, as applicable.
 </li>
 <li>
 Support review and analysis of safety content for study protocols, CRFs, IB/RSIs, ICFs, SMPs, CSRs, DMC meetings, and coding reviews, as applicable.
 </li>
 <li>
 Demonstrate knowledge and stay up to date to ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)
 </li>
 <li>
 Contribute to process improvement and consistency of cross-product processes.
 </li>
 <li>
 Maintain inspection readiness.
 </li>
 <li>
 Perform other tasks as assigned or required.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 What You&rsquo;ll Bring:
 
 
 
 <ul>
 <li>
 1+ years relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety serving in a PV Scientist or similar role.
 </li>
 <li>
 Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS).
 </li>
 <li>
 Demonstrated experience in analysis and interpretation of medical and scientific data.
 </li>
 <li>
 Excellent oral and written communication skills.
 </li>
 <li>
 Demonstrated ability to work effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, Biostatistics, etc.) as well as independently.
 </li>
 <li>
 Ability to apply clinical judgment to interpret case information.
 </li>
 <li>
 Knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations.
 </li>
 <li>
 Familiarity with case processing, expedited reporting rules, and safety database concepts.
 </li>
 <li>
 Proficiency with Microsoft Office Suite and Argus Safety systems.
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $135,000 - $189,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
 
 
 Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera&rsquo;s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)
 
 
 
 Benefits
 
 
 
 <ul>
 <li>
 Competitive salary and annual bonus.
 </li>
 <li>
 Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
 </li>
 <li>
 Generous parental leave and family planning benefits.
 </li>
 <li>
 Outstanding culture and opportunities for personal and professional growth.
 
 
 </li>
 </ul>
 
 Apply Now:
 
 Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
 
 
 
 EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
 
 
 
 Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
</div>

Pharmacovigilance Scientist

Skill required: Pharmacovigilance Services - Pharmacovigilance &amp; Drug Safety Surveillance 
Designation: Pharmacovigilance Services Sr Analyst 
Qualifications:Bachelor of Pharmacy/Bachelor Degree in Life Sciences
 
Years of Experience:5 to 8 years
 
About Accenture 
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song&mdash; all powered by the world&rsquo;s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
 
What would you do? You will be aligned with our Life Sciences R&amp;D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance &amp; Regulatory, helping the world&acirc;&euro;&trade;s leading biopharma companies bring their vision to life &acirc;&euro;&ldquo; enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. 
What are we looking for? &bull;Ability to perform under pressure &bull;Adaptable and flexible &bull;Problem-solving skills &bull;Detail orientation &bull;Ability to establish strong client relationship
 
Roles and Responsibilities: &bull;In this role you are required to do analysis and solving of increasingly complex problems &bull; Your day to day interactions are with peers within Accenture &bull; You are likely to have some interaction with clients and/or Accenture management &bull; You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments &bull; Decisions that are made by you impact your own work and may impact the work of others &bull; In this role you would be an individual contributor and/or oversee a small work effort and/or team &bull; Please note that this role may require you to work in rotational shifts
 
Bachelor of Pharmacy,Bachelor Degree in Life Sciences

Pharmacovigilance Services Sr Analyst

Eli Lilly

<div>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.
PHARMACOVIGILANCE INTERN 
Pharmacovigilance Intern is responsible from providing support for maintenance of pharmacovigilance system in Turkey affiliate. 
RESPONSIBILITIES:
<ul><li> Providing support for conducting follow-up activities for adverse events</li><li> Performing monthly quality checks</li><li> Preparing literature screening logs</li><li> Translation of necessary records</li><li> Tracker monitorization for related business process</li><li> Documentation for expedited and periodic submissions and case management activities</li><li> Organising local archive and daily tracking of shiploads as well as supporting all the processes of the team the one is affiliated with.</li></ul> 
QUALIFICATIONS<ul><li> 4th or 5th grade Pharmacy student or new graduate</li><li> Ability to work at least 4 days a week for 6 months</li><li> Good command of English</li><li> Effective communication skills</li><li> Good planning and organisational skills</li><li> Prone to teamwork</li><li> Good use of MS Office programs</li></ul>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly</div>

Pharmacovigilance Intern

Skill required: Pharmacovigilance Operations - Pharmacovigilance &amp; Drug Safety Surveillance 
Designation: Pharmacovigilance Services Associate 
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
 
Years of Experience:1 to 3 years
 
About Accenture 
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song&mdash; all powered by the world&rsquo;s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
 
What would you do? You will be aligned with our Life Sciences R&amp;D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance &amp; Regulatory, helping the world&acirc;&euro;&trade;s leading biopharma companies bring their vision to life &acirc;&euro;&ldquo; enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. 
What are we looking for? Looking for Drug Safety Associate
 
Roles and Responsibilities: &bull;In this role you are required to solve routine problems, largely through precedent and referral to general guidelines &bull; Your expected interactions are within your own team and direct supervisor &bull; You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments &bull; The decisions that you make would impact your own work &bull; You will be an individual contributor as a part of a team, with a predetermined, focused scope of work &bull; Please note that this role may require you to work in rotational shifts
 
Bachelor of Pharmacy,Master of Pharmacy

Pharmacovigilance Services Associate

Skill required: Pharmacovigilance Services - Pharmacovigilance &amp; Drug Safety Surveillance 
Designation: Pharmacovigilance Services Analyst 
Qualifications:Bachelor of Dental Surgery/Bachelor of Pharmacy/Bachelor Degree in Life Sciences
 
Years of Experience:3 to 5 years
 
About Accenture 
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song&mdash; all powered by the world&rsquo;s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
 
What would you do? You will be aligned with our Life Sciences R&amp;D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance &amp; Regulatory, helping the world&acirc;&euro;&trade;s leading biopharma companies bring their vision to life &acirc;&euro;&ldquo; enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. 
What are we looking for? &bull;Adaptable and flexible &bull;Ability to perform under pressure &bull;Problem-solving skills &bull;Detail orientation &bull;Ability to establish strong client relationship
 
Roles and Responsibilities: &bull;In this role you are required to do analysis and solving of lower-complexity problems &bull; Your day to day interaction is with peers within Accenture before updating supervisors &bull; In this role you may have limited exposure with clients and/or Accenture management &bull; You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments &bull; The decisions you make impact your own work and may impact the work of others &bull; You will be an individual contributor as a part of a team, with a focused scope of work &bull; Please note that this role may require you to work in rotational shifts
 
Bachelor of Dental Surgery,Bachelor of Pharmacy,Bachelor Degree in Life Sciences

Pharmacovigilance Services Analyst

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