As a seasoned professional in pharmacovigilance, you have the opportunity to take on a key role in ensuring patient safety and regulatory compliance. This position involves processing cases and reporting individual case safety reports (ICSRs) in a timely manner. You will also be responsible for maintaining global safety databases, screening literature for ICSRs and safety information, conducting periodic case reconciliations with clients and business partners, drafting pharmacovigilance agreements (PVAs), preparing signal detection reports, risk management plans (RMPs), periodical safety update reports (PSURs) ,pharmacovigilance system master files(PSMF)
Responsibilities:
* Maintain quality systems
* Process ICSR's
* Cases Reconcilliation
* Draft Pharmacovgilience Agreements(PVA)
This is an exciting opportunity to work with a dynamic team that prioritizes patient safety and compliance.
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We are seeking individuals who are passionate about upholding high standards of care while driving commercial growth.