Pharmacovigilance Process Officer
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Pharmacovigilance Process Officer

Descripción de la oferta

? Assist in the maintenance of company compliance with respect to processes described in local PV legislation and Bayer?s QSDs. Supports the implementation and overview of safety-related processes in Colombia and allocated countries to the Andean CoE.
? Keep current with emerging applicable local PV laws, regulations and guidelines, as well as local and global QSDs.
? Responsible for PV governance activities, including reconciliation and spot QC, with internal and external sources of AE reports. Ensure overview of these activities by liaising with the global, local organization(s) and third parties as applicable.
? Provides support in the PV oversight of PSPs/CRSs including vendor liaison and compliance with safety-related processes.
? Ensure the draft, negotiation and finalization process of PV Agreements for local PV relevant contracts.
? Coordinate training activities for PV and non-PV staff, including newcomers, tracking and documenting activities, monitor and update of training materials.
? Supports the overview of the process of local PV owned QSDs? update, implementation, publication and training to affected functions.
? Perform self-inspection management to ensure fulfillment of PV processes as described in the country PV Quality Checklist .
? Support the PVCH in the activities related to financial and budget target.
? Support and fulfill administrative tasks as applicable.




1 año de experiencia

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