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You would be a contributor to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance including electronic pharmacovigilance system, adverse drug experience (ADE) reports, trending reports, ADE
Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs), including development, execution, maintenance, and termination where applicable, along with all associated deliverables. Contribute to strategy setting in collaboration with line
The Senior GVP QA Manager is responsible for supporting the maintenance and continuous improvement of the global Pharmacovigilance (PV) System to ensure that Santhera fulfils its legal PV obligations as both a Marketing Authorisation Holder (MAH) and
Primary responsibilities include medical and safety oversight of clinical trials as well as corporate support for business opportunities. The Medical Director provides Medical Monitoring services to clinical trials with the aim to monitor the safety and
Support clinical development of the product by leading the delivery of safety driven activities across the full development programme - from FIH studies through to regulatory submission – in close collaboration with cross-functional Asset Team members.