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 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 and clinical assessment of ICSRs.
- ICSR causality, seriousness, and expectedness assessment.
- Line listing and product safety review.
- Benefit-risk assessment and aggregate report medical input.
- Regulatory query and safety assessment experience.
- Strong clinical judgment, analytical skills, attention to detail, and communication skills.
- System and Domain Exposure
- Pharmacovigilance safety databases such as Argus, LSMV, or equivalent.
- ICSR processing and medical review workflows.

📌 Drug Safety Physician (India)
🏢 Soterius
📍 India