Medical Reviewer – Pharmacovigilance (5-10 yrs experience)

About the role

The Medical Reviewer – Pharmacovigilance will evaluate adverse event reports, perform causality assessments, and support signal detection activities. This position requires strong medical expertise and familiarity with international regulatory guidelines to ensure patient safety and compliance.

Key responsibilities

• Triaging adverse event reports in the Argus database.
• Conducting medical review and causality assessment of individual case safety reports (ICSRs) in Argus.
• Participating in signal management and safety signal detection activities.
• Reviewing aggregate safety reports and preparing medical assessments.
• Evaluating, comparing, and updating Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) as required.

Required profile

• Medical degree (M.B.B.S.) with any specialization, or an MS/MD in any specialization.
• 5 to 10 years of experience in pharmacovigilance or drug safety.
• Strong interpersonal skills and ability to adapt to varying environments.
• Excellent attention to detail and sound decision‑making abilities.

Required skills

• Expert knowledge of international guidelines and country‑specific regulatory requirements (FDA, ICH GCP, GVP modules, EU Clinical Trial Directive, etc.).
• Experience with ICSR review and assessment.