Roles & Responsibilities:
• Perform quality control of vigilance cases.
• Conduct medical evaluation of safety reports.
• Data entry of vigilance cases into agreed databases/formats.
• Follow-up of vigilance cases via phone and email.
• Pre-analysis of complex cases prior to data entry.
• Medical evaluation of files including coding, causality assessment, expectedness, and seriousness of events.
• Identify submission requirements for each case.
• Validate documents prepared by Data Managers/Vigilance Associates.
• Close vigilance case files in compliance with regulations.
• Define and implement ICSR/MLM filters and applicable changes.
• Analyze inclusion/exclusion of EV/MHRA cases.
• Provide medical information support and handle safety-related calls.
• Review medical information queries and quality complaints to identify safety information.
• Act as key contact for specific clients and prepare quality documents as required.
Qualification:
• Doctor of Pharmacy / Pharmacist
Experience:
• 1–3 years of experience in a similar Pharmacovigilance role
• Knowledge of Pharmacovigilance is an advantage
Skills:
• Experience with safety databases preferred
• Knowledge of current PV regulations
• Process-oriented, detail-focused, and team player
• Proficient in Microsoft Office tools
• Strong multitasking and flexibility
• Excellent communication skills in French and English
About the Organisation:
ProductLife Group is a global life sciences consulting and services company providing integrated solutions across pharmacovigilance, regulatory affairs, quality, and compliance, supporting pharmaceutical, biotechnology, and medical device companies worldwide throughout the entire product lifecycle.
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