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Serve as the main contact point to support the local pharmacovigilance responsible person (LPVRP) in the assigned region, where applicable; Support the Head of Regional PV in the harmonization of processes across the regions
Oversee key regulated activities including distribution, storage, import/export, promotion, medical information, and quality documentation. Support the implementation and continuous improvement of a fit-for-purpose local Quality Management System.
The role is accountable for proactive safety surveillance, signal management, benefit–risk evaluation, and risk mitigation activities, in close partnership with Drug Safety & Pharmacovigilance internal team and cross-functional stakeholders
Takes responsibility for oversight and monitoring of the system for collection, processing, reconciliation and reporting of ICSRs for the DSE region. This includes ensuring ICSR report intake, case processing, workflow monitoring, follow-up requests,