Pharmacovigilance Manager
1 week ago
PATH is a global nonprofit dedicated to achieving health equity. With over 40 years of experience forging multisector partnerships and expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world's most pressing health challenges.
About the PositionJob SummaryThe Pharmacovigilance Manager will support PATH's CVIA Clinical team in setting up, implementing, and overseeing post-authorization vaccine pharmacovigilance activities to assess the risk/benefit of new vaccines.
Key Responsibilities- Establish and strengthen pharmacovigilance capabilities of vaccine manufacturers based in LMICs.
- Monitor the risk/benefit of vaccines newly introduced into the public health programs of LMICs.
- Develop training programs on pharmacovigilance topics for vaccine manufacturers based in LMICs.
- Work with vaccine manufacturers to provide sustained technical support to maintain and further develop competencies related to pharmacovigilance.
- Draft responses to pharmacovigilance requests from regulatory agencies.
- Present technical updates and represent PATH at scientific, global health, and major national and international meetings.
- Facilitate communication and participate in collaborative efforts related to pharmacovigilance with all PATH vaccine program staff, partners, collaborators, and funders.
- M.D. or other equivalent doctorate degree in a related scientific discipline with 10 or more years of experience in supporting post-authorization pharmacovigilance activities at increasingly responsibility levels and in different capacities in pharmaceutical or vaccine industry.
- Extensive knowledge of pharmacovigilance requirements by USFDA, EMA, and other international normative and regulatory agencies.
- Experience in routine PV activities like periodic safety update report writing, signal detection activities, medical review of individual case safety reports.
- Hands-on experience in PV safety database operations.
- Knowledge and understanding of clinical development, clinical trial standards, and safety data analyses.
- Experience in developing/ implementing/ overseeing public health programs related to safety evaluations of new vaccines.
- Knowledge of vaccine pre-qualification requirements of the WHO.
New Delhi
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