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Role & Responsibilities
• Perform medical review and approval of post-marketing ICSRs and clinical trial SAE reports
• Assess seriousness, expectedness, causality and coding accuracy of safety cases
• Prepare company medical comments, follow-up queries and similar event analysis
• Complete and maintain safety trackers and supporting documentation
• Support the Qualified Person for Pharmacovigilance in evaluation of safety issues
• Review and provide medical input into periodic safety reports
• Review literature screening strategies and evaluate articles for safety case identification
• Contribute to medical evaluation of safety signals and ongoing risk assessment
Qualification
• MD (Doctor of Medicine)
Experience
• Open to Medical Doctors seeking entry or early-career growth in pharmacovigilance
Skills
• Strong understanding of pharmacovigilance principles and safety reporting
• Ability to plan, organize, prioritize and manage multiple safety tasks
• Excellent written and verbal English communication (minimum B2 level)
• Strong presentation and documentation skills
• Advanced proficiency in MS Office tools
• Ability to work effectively across cultures and cross-functional teams
About the Company
PrimeVigilance is a global pharmacovigilance and regulatory affairs organization with operational presence across North America, Europe and Asia, supporting pharmaceutical and biotech companies with end-to-end drug safety, medical information and risk management services.