Drug Safety Physician

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

1. Perform medical review of ICSRs, including causality, seriousness, and expectedness assessment.
2. Conduct line listing review for non-serious 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.

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