Quality Assurance and Pharmacovigilance Expert
vor 2 Wochen
**COMPANY** **ALTOGEN** is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert level consultants with strong development potential, whom we support in their professional goals. **ABOUT THE JOB**: - To represent PVQA for Pharmacovigilance System - To support company/ Supplier/Vendor teams (e.g. GDS, GMA, Marketing, affiliate) in staying compliant with regulatory requirements (e.g. answering questions; participating to meeting to discuss PV issues) - To help/complete PSMF part under responsibility of PVQA - To escalate serious / continuing non-compliance PV issues as appropriate/necessary - To organize and/or help with trainings on PV requirements - To organize and/or help presentation on PV important topics (e.g. PVQA audit finding, PV inspection) - To help/contribute to PV process improvements (e.g. via audit finding / CAPA) - To manage PV deviation as per Deviation QS documents - To help/contribute to PV electronic systems (e.g. Testing Quality Event Module) - To help with trouble shooting for Idorsia processes and systems - To contribute to obtain efficient Pharmacovigilance as indicated by relevant Key Performance Indicator (KPI) - To lead/participate in management of PV inspections (e.g. preparation, follow up) by (international) regulatory authorities - To facilitate the PV inspection CAPAs elaboration, approval and follow-up for PVQA manager expected to be also an PVQA Auditor as defined in company’s SOP-101134: - To work as per the defined strategy for the global PV audit program - To plan, perform, and report standards GVP audits (e.g. affiliate, supplier, process, studies) - To be in charge of CAPAs evaluation/review follow-up and closure - To assist Senior colleagues - To perform any other PVQA task that could help to achieve a high adherence to PV requirements **ABOUT YOU**: - At least a bachelor degree or equivalent education/degree in Life sciences or healthcare - At least 3 years of experience within pharmaceutical industry/health authority - Good knowledge of GVP regulatory requirements and pharmaceutical industry practices - At least 1 year experience in Quality Assurance (QA) within the GxP environment (alternatively experience in operational / regulatory department / safety/pharmacovigilance operation / department with a role implying quality work could be also considered equivalent) - Experience in GxP quality systems, compliance monitoring, CAPA management, and/or the development and maintenance of standards and training programs - Investigation, problem solving, risk analysis & management, negotiation and influencing skills - Interest / knowledge of GxP computerized systems used in pharmacovigilance (e.g. QMS, Safety Database, Medical Information) - Fluent in English **Travels are to be planned.** **WHAT WE OFFER**: - A permanent contract and innovative projects - An attractive remuneration policy - Personalized management and continuous learning to develop your career - Great team spirt and an integration within the "Tribe" **Job Type**: 100% Schedule: - Monday to Friday Work Location: In person
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Quality Assurance and Pharmacovigilance Expert
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