Senior Pharmacovigilance Expert for Vaccine Safety

1 week ago


Delhi, Delhi, India PATH Full time

About PATH

PATH is a global nonprofit dedicated to achieving health equity through innovative solutions.

We are seeking a Senior Pharmacovigilance Expert for Vaccine Safety to join our team in New Delhi, India.

Job Description

The Senior Pharmacovigilance Expert will work closely with vaccine manufacturers and regulatory agencies to ensure the safe use of vaccines in low- and lower-middle-income countries.

Key Responsibilities:

  • Provide technical support to vaccine manufacturers to develop and implement pharmacovigilance systems.
  • Conduct regular meetings with vaccine manufacturers to ensure smooth implementation of pharmacovigilance activities.
  • Participate in gap analysis of current PV systems and provide inputs for system development.
  • Create SOPs, SOP templates, and other PV tools under guidance.
  • Develop training materials for LMIC public health agencies and vaccine manufacturers.
  • Impart trainings on pharmacovigilance topics.
  • Draft responses to pharmacovigilance requests from regulatory agencies.
  • Presentation of technical updates and representation at scientific, global health, and national meetings.
  • Facilitate communication and participate in collaborative efforts related to pharmacovigilance with all PATH vaccine program staff, partners, collaborators, and funders.
  • 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.

Requirements

To be successful in this role, you will need:

  • A Doctorate degree (M.D. or equivalent) in a related scientific discipline with 10+ years of experience in supporting post-authorization pharmacovigilance activities.
  • 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 with excellent written and verbal communication skills.
  • Strong analytical, problem-solving skills, leadership abilities, and self-motivation.

Location and Salary

New Delhi, India | $120,000 - $150,000 per annum



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