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-serious cases in line with program SOPs.
- Provide benefit-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
