Drug Safety Physician
About the Role
Role & Responsibilities
• Perform medical review of Individual Case Safety Reports (ICSRs)
• Ensure medical accuracy, completeness, and regulatory compliance of safety cases
• Apply clinical judgment for case assessment, seriousness, causality, and expectedness
• Support global pharmacovigilance and regulatory reporting activities
• Ensure adherence to GVP, ICH guidelines, and internal SOPs
Qualifications & Experience
• MBBS / MD with valid MCI registration
• Minimum 1 year of hands-on experience in ICSR medical review
Skills
• Strong knowledge of pharmacovigilance and clinical terminology
• Understanding of regulatory reporting requirements
• Good analytical and documentation skills
About the Company
• Indegene is a global life sciences solutions provider delivering pharmacovigilance, medical affairs, and regulatory services across worldwide markets
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