Senior Manager - Pharmacovigilance

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PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing heath challenges. 

PATH’s CVIA conducts research, clinical development, introduction, and post-marketing activities for vaccines in the following disease areas: malaria, diarrheal diseases, polio, respiratory tract infections, meningitis, HPV and vector-borne viral diseases. CVIA’s goals are prove the safety and efficacy of selected vaccine candidates in phase 1-4 clinical trials, support their introduction into public health systems and evaluate their effectiveness and safety as they are introduced. In these endeavors, CVIA works closely with international vaccine manufacturers from early development through post-marketing effectiveness and pharmacovigilance (PV) surveillance activities. CVIA works in alignment with the programs and initiatives of WHO and its funders to efficiently expedite the application of life-saving vaccines across low- and lower middle-income countries (LMICs).
 

The Pharmacovigilance Group in CVIA Clinical team, where the Senior Manager - Pharmacovigilance position resides, works closely with other CVIA 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 LMICs.  The incumbent will support CVIA and its international partners in setting up, implementing, and overseeing post-authorization vaccine pharmacovigilance activities to assess the risk / benefit of new vaccines. Specifically, the incumbent will provide inputs in:

• Establishing and strengthening pharmacovigilance capabilities of vaccine manufacturers based in LMICs.

• Monitoring the risk/benefit of vaccines newly introduced into the public health programs of LMICs.

• Developing training programs on pharmacovigilance topics for vaccine manufacturers based in LMICs.
   

The position reports to the Director, Pharmacovigilance.

JOB DUTIES AND RESPONSIBILITIES

• Work with and otherwise coordinate with vaccine manufacturers to provide sustained technical support to maintain and further develop competencies related to pharmacovigilance.

  • Actively interact with company and conduct regular meetings and updates to ensure smooth implementation.

  • Actively participate in gap analysis of current PV system and provide inputs for systems development to address the gaps.

  • Create SOPs, SOP templates and other PV tools under guidance.

  • Develops training materials for LMIC public health agencies, and vaccine manufacturers, and participates in pharmacovigilance training programs in conjunction with other CVIA staff.

  • Impart trainings.

  • Drafts 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, including industry, academia, government agencies, multilateral health organizations and non-governmental organizations.

• Adhere to timelines provided and proactively identify and escalate risks in a timely fashion.

• Oversee adherence to Good Clinical Practices, human subject research protection, local and international regulations, and protocol-specific procedures applied to CVIA’s pharmacovigilance efforts.

• Keep abreast of new developments in pharmacovigilance practices and requirements from regulatory and other health authorities (e.g., WHO); maintain current knowledge of and anticipate changes in the landscape of vaccine pharmacovigilance.

• Maintain awareness of medical / scientific literature related to the risk/benefit of vaccines.
   

REQUIRED SKILLS

• M.D. (Doctor of Medicine), or other equivalent medical degree, or doctorate degree in related scientific discipline with 12 or more years of experience in supporting post—authorization pharmacovigilance activities at increasingly responsibility levels and in different capacities in pharmaceutical or vaccine (preferrable) 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.

• Articulate communicator, excellent written and verbal communication skills (English language essential), with strong interpersonal and presentation skills.

• Self-motivated, with leadership abilities.

• Strong analytical, and problem-solving skills.

• Ability to work in a small team in a global environment. Open, engaging, and transparent work style with a global perspective and mindset; ability to work effectively with colleagues from myriads of cultures, backgrounds, and geographies.

• Ability to travel up to 20%.

• Desirable: Experience in developing / implementing / overseeing public health programs related to safety evaluations of new vaccines.

• Desirable: Knowledge of vaccine pre-qualification requirements of the WHO.
   

Location: New Delhi