Drug Safety Team Leader, Deputy Qppv
hace 2 días
Overview: Ensuring legal and regulatory compliance with the pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP). As Drug Safety Team Leader, coordinating part of the staff and the activities related to PV system, QMS, safety from clinical trials, aggregate reports, safety variations. As EU & UK deputy of the qualified person responsible for pharmacovigilance (Deputy QPPV), being responsible of the pharmacovigilance system in the absence of the QPPV. **Responsibilities**: - As deputy QPPV, to act as QPPV in the absence of the last. - Collaborate in the maintenance of the Pharmacovigilance System Master File. - Ensure readiness for audits and inspections, collaborate with QA PV staff in the management of deviations/CAPA plan. - Collaborate in the maintenance of the Quality Management System of Chemo Organization, giving support in the elaboration and update of Global Standard Operating Procedures (SOPs). - Active collaboration on pharmacovigilance activities related to clinical investigation: reviewing and management of safety in clinical protocols (AE/SAE/SUSAR), organization of DSUR, reconciliations with CRO, reviewing CSR. - Collaborate in the Signal Committee and signal detection processes. - Ensure proper preparation, review and submission of safety reports (periodic safety update reports (PSUR), risk management plans (RMP) and renewals. - Supervise the implementation of additional risk minimization measures (aRMM). - Collaborate in the coordination of response to the Spanish and foreign country health authorities. - Supervise the implementation of the training programs and ensure proper training of the employees. - Supervise the elaboration, management, follow-up and implementation of PV contracts and agreements with third parties and collaborate in the service providers contracts. - Keep PV files safe, accurate, updated and complete, in compliance with internal standards and applicable regulations. - Collaboration on vigilance activities related to medical device incidents (management of cases, evaluation, submission, archive). - Ensure adequate interface and communication with other departments performing activities impacting Chemo PV system, such as Regulatory Affairs, Medical, Legal, Marketing, Commercial departments. Qualifications: - **Education**: University Degree in Health Sciences (Pharmacy, Medicine, Odontology). In case of Biology, Biotechnology, etc., it shall be necessary a Health Science orientation. - ** Languages**: Fluent English and Spanish, knowledge of other languages will be an asset. - **Experience (years/area)**:At least 1 year in similar positions (Team Leader, Local contact person for PV, Team manager, etc., and at least 5 years of experience in a Pharmacovigilance department in a medium-large pharmaceutical company, preferably demonstrating responsibilities for global PV tasks. Knowledge and excellence in quality systems for PV and Good Pharmacovigilance Practices. - ** Specific Knowledge**: Expert in Pharmacovigilance (master/post-graduate or similar training through specific courses), national and European legislation related to pharmacovigilance, knowledge on European Pharmacovigilance System (EVWEB/EVDAS), safety databases (PcV Manager, Arisg, Argus, etc.). - ** Travels**:Willingness to travel
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