• Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical and causality assessments.
• Assess the seriousness, expectedness, and causality of reports.
• Write company comments, follow-up questions, and perform analysis of similar events.
• Complete required supporting documentation such as trackers.
• Support the Qualified Person for Pharmacovigilance (QPPV) in evaluating safety issues (if not medically qualified).
• Provide input for periodic reports.
• Review literature screening search strategies and articles to determine safety findings or ICSRs/SAEs related to the relevant medicinal products.
• MD (Medical Doctor)
• Experience in Pharmacovigilance, preferably with exposure to ICSR handling and safety reporting
• Strong understanding of drug safety regulations and practices
• Ability to plan, organize, prioritize, and execute multiple tasks
• Strong communication and presentation skills
• Ability to work cross-culturally and functionally as part of a global team
• Advanced English skills (both verbal and written), at least B2 level
• Advanced knowledge of MS Office
• PrimeVigilance is a global pharmacovigilance and drug safety service provider. The company offers an opportunity for medical doctors to build and develop their careers in drug safety.
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