- Medical review and assessment of ICSRs, including seriousness, listedness and causality.
- Review case narratives, coding, labeling, medical history and supporting documents.
- Perform medical sign-off and quality review of safety cases.
- Support literature surveillance and safety data analysis.
- Contribute to aggregate safety reporting, safety assessments and risk management activities.
- Ensure compliance with global Pharmacovigilance regulations, SOPs and quality standards.
- Collaborate with stakeholders and provide medical expertise, feedback and guidance.
? What We’re Looking For
- Strong hands-on experience in Pharmacovigilance and Drug Safety.
- Good knowledge of safety databases, PV processes and compliance requirements.
- Robust medical, analytical and critical-thinking skills.
- Excellent communication and interpersonal skills.
- Attention to detail and commitment to quality and timelines.
📌 Senior Drug Safety Physician (Bengaluru)
🏢 Indegene
📍 Bengaluru
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