Pharmacovigilance Expert Leader
6 days ago
At PATH, we are committed to achieving health equity by forging multisector partnerships and developing innovative solutions to the world's most pressing health challenges.
We are seeking an experienced Pharmacovigilance Manager to join our Clinical team, where you will work closely with other programs (Regulatory; CMC; and Policy, Access, and Introduction [PAI]), funders, and partners in the regulatory submission, post-licensure evaluation of vaccine products, and their initial adoption in low- and lower middle-income countries (LMICs).
This is an excellent opportunity to contribute to the development and implementation of pharmacovigilance strategies that ensure the safety and efficacy of vaccines. As a Pharmacovigilance Manager, you will provide technical support to vaccine manufacturers based in LMICs, establish and strengthen their pharmacovigilance capabilities, and develop training programs on pharmacovigilance topics.
The successful candidate will have extensive knowledge of pharmacovigilance requirements by international regulatory agencies, experience in routine PV activities such as periodic safety update report writing, signal detection activities, medical review of individual case safety reports, and hands-on experience in PV safety database operations.
You will be responsible for creating SOPs, SOP templates, and other PV tools under guidance, developing training materials for LMIC public health agencies, and vaccine manufacturers, and participating in pharmacovigilance training programs. You will also facilitate communication and participate in collaborative efforts related to pharmacovigilance with all PATH vaccine program staff, partners, collaborators, and funders.
As a leader, you will oversee adherence to Good Clinical Practices, human subject research protection, local and international regulations, and protocol-specific procedures applied to CVIA's pharmacovigilance efforts. You will maintain awareness of medical/scientific literature related to the risk/benefit of vaccines and stay up-to-date with new developments in pharmacovigilance practices and requirements from regulatory and other health authorities.
We offer a competitive salary of $120,000 per year and a benefits package that includes comprehensive health insurance, paid time off, and retirement plan matching. If you are passionate about contributing to global health equity and have the required skills and experience, please apply for this exciting opportunity.
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Pharmacovigilance Manager
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Delhi, Delhi, India PATH Full timeAbout PATHPATH 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...
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