• Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment.
• Review includes coding, assessment of seriousness, expectedness, and causality.
• Write Company comments, follow-up questions, and analyze similar events.
• Complete all required supporting documentation, such as trackers.
• Support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues.
• Review and provide input in periodic reports.
• Review literature screening search strategies and review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings.
• MD qualification is required.
• Proven ability to plan, organize, prioritize, and execute multiple tasks efficiently.
• Ability to work cross-culturally and cross-functionally, valuing teamwork.
• Strong communication and presentation skills.
• Advanced English skills, both verbal and written (at least B2 level).
• Advanced knowledge of MS Office.
• PrimeVigilance offers an opportunity for Medical Doctors to develop a career in Drug Safety.The company’s Pharmacovigilance Physician team operates across North America, Europe, and Asia, providing global pharmacovigilance services.
PrimeVigilance is focused on creating a collaborative, high-quality environment for physicians interested in pharmacovigilance.
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