Providing support to safety pharmacovigilance physician in conducting safety surveillance of assigned products. Prepare and manage the aggregate reports draft, finalization and submission timelines by working closely with CROs and relevant department contributors. Support the safety pharmacovigilance physician in drafting the safety sections of aggregate reports, IB, protocols, health authority responses, data management or safety management committee presentations and other similar activities. Accountable for the delivery of assigned tasks according to quality, time, budgets, and resources. Liaise with case processing team internally and CROs to ensure timely delivery of all case processing and health authorities’ commitments for PV safety. Partner with pharmacovigilance operations, clinical development and operations, regulatory and other functional areas for the successful implementation and execution of all PV commitments. Act as a safety pharmacovigilance resource in interactions with internal and external stakeholders.
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