Senior Drug Safety Physician
About the Role
About Role & Responsibilities
• Review, assess and medically evaluate adverse event reports
• Ensure accurate medical coding and causality assessment
• Provide medical oversight for ICSR processing and signal detection
• Support aggregate safety reporting and regulatory submissions
• Participate in safety governance and risk management activities
• Liaise with regulatory authorities and global stakeholders
Qualification
MBBS / MD
Experience
Minimum 5+ years in pharmacovigilance or clinical safety
Skills
• ICSR processing
• Medical review & causality assessment
• Aggregate safety reports (PSUR, PBRER, RMP)
• Regulatory compliance
• Excellent documentation and communication skills
About the Company
Indegene is a global healthcare solutions company providing technology-driven services across medical, regulatory and safety domains to leading pharmaceutical and life-science companies worldwide
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