Monitors pharmacovigilance regulations and guidelines to be aware of updates.
Assists in the performance of pharmacovigilance process activities, i.e., case processing, literature screening, aggregate reporting, risk management, signal management, safety variations, safety agreements, to ensure these are performed in compliance with regulations and guidelines, with high quality and within the required timelines.
Assists in the preparation of pharmacovigilance documents, i.e., aggregate reports, risk management plans, signal detection reports, safety variations, safety agreements.
Follows-up on regulatory submission/distribution to local health authorities and archiving of all safety reports to ensure that health authorities requirements are fulfilled within the defined timelines.
Aids in the updates of the global product database to ensure it serves as a reliable and up to date source for product information.
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