Medical Reviewer – Pharmacovigilance

About the role

The Medical Reviewer will perform comprehensive medical evaluation of Individual Case Safety Reports (ICSRs) and support clients in meeting pharmacovigilance (PV) regulatory requirements. The role may also involve literature review, aggregate safety reporting, signal management, and other PV activities across assigned projects.

Key responsibilities

• Conduct medical review of trial‑related adverse events and post‑marketing adverse drug reactions, including narrative writing, coding, expectedness, seriousness, causality assessment, and summary preparation.
• Compose and medically review Analyses of Similar Events (AOSE) for expedited cases.
• Perform literature review and analysis to support safety assessments.
• Serve as a subject‑matter expert and internal consultant to case‑processing teams.
• Participate in audits, inspections, and signal‑management committee meetings.
• Provide feedback, training, and mentorship to case processors and new team members.
• Contribute to quality‑control initiatives and process‑improvement activities.

Required profile

• MBBS/MD, BDS/MDS or comparable medical qualification.
• 1–2 years of experience as a Medical Reviewer handling ICSR data in a pharmacovigilance setting.
• Strong understanding of drug‑induced diseases, medical devices, vaccines, and the drug development lifecycle.
• Ability to stay current with product safety profiles across therapeutic areas.

Required skills

• Pharmacovigilance and adverse event coding.
• Signal management and safety data analysis.
• Literature review and scientific evaluation.
• Regulatory reporting (e.g., PADER, PBRER, PSUR, ACO).
• Medical writing and review of safety aggregate reports.