maintaining a system which ensures that any emerging safety concern or adverse reactions is detected and reported to the EPVC.
• Performing literature searches and obtaining literature articles and reviews, to guarantee up to date information.
• Preparation of adverse events and Adverse Drug Reactions in the appropriate format to be submitted to the EPVC, in compliance with the timelines.
• Maintain an up-to-date knowledge of pharmacovigilance regulations.
• Organization of all cases into a comprehensive documentation system.
• Follow up, validation & assessment of ICSRs.
• Report writing using MedDRA coding.
• Monitoring of changes to the pharmacovigilance guidelines.
• Preparation of periodic benefit risk evaluation reports (PBRERs).
• Preparation of risk management plan (RMP)
Bachelor of PharmacyPrevious experience in pharmacovigilance is preferable