Role Overview

Responsible for the medical review of adverse event cases within a large-volume OTC/consumer healthcare pharmacovigilance program. Provides clinical judgment across case processing and aggregate report activities.

Qualifications and Experience
1 to 2 years of experience in pharmacovigilance, drug safety, or clinical safety.
MBBS, MD in Pharmacology.

Key Responsibilities
Perform medical review of ICSRs, including causality, seriousness, and expectedness assessment.
Conduct line listing review for non-responsible cases in line with program SOPs.
Provide advantage-risk evaluation and medical input.
Provide medical input to aggregate reports.
Support responses to medical aspects of regulatory queries.
Support product safety and consumer health safety assessments.
Ensure medical review activities meet quality and compliance standards.
Escalate safety concerns and complex cases appropriately.

Key Skills
Medical review;
ICSR causality, seriousness and expectedness assessment;
Line listing review;
Benefit-risk evaluation;
Aggregate report medical input;
Product safety;
Consumer health and OTC;
Regulatory query support

📌 Drug Safety Physician Mumbai
🏢 Soterius
📍 Mumbai