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

Key Responsibilities

1. Perform medical review of ICSRs, including causality, seriousness, and expectedness assessment.
2. Conduct line listing review for non-reliable cases in line with program SOPs.
3. Provide benefit-risk evaluation and medical input.
4. Provide medical input to aggregate reports.
5. Support responses to medical aspects of regulatory queries.
6. Support product safety and consumer health safety assessments.
7. Ensure medical review activities meet quality and compliance standards.
8. Escalate safety concerns and complex cases appropriately.

Key Skills

1. Medical review and clinical assessment of ICSRs.
2. ICSR causality, seriousness,



and expectedness assessment.
3. Line listing and product safety review.
4. Benefit-risk assessment and aggregate report medical input.
5. Regulatory query and safety assessment experience.
6. Strong clinical judgment, analytical skills, attention to detail, and communication skills.
7. System and Domain Exposure
8. Pharmacovigilance safety databases such as Argus, LSMV, or equivalent.
9. ICSR processing and medical review workflows.

Required Skills

MBBS MD benefit-risk line listing review seriousness expectedness medical review Physician consumer health aggregate report medical input ICSR causality product safety

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Drug Safety Physician (Mumbai)
🏢 Soterius Life Sciences
📍 Mumbai