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Role & Responsibilities
• Review and perform medical assessment of Individual Case Safety Reports (ICSRs)
• Conduct causality assessments and MedDRA coding
• Review literature cases and write safety narratives
• Support the preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and aggregate safety reports
• Ensure compliance with global pharmacovigilance (PV) regulations
Qualification
• MBBS / MD
Experience
• 1–2 years of Pharmacovigilance experience
• Hands-on experience in ICSR review and aggregate reporting
Skills
• Strong knowledge of MedDRA coding and causality assessment
• Proficient in safety narrative writing and literature review
• Familiarity with global PV regulations
About the Company
• Sun Pharmaceutical Industries Ltd. is one of India’s largest global pharmaceutical companies.