Qa R&D Pharmacovigilance Specialist

2 settimane fa

Milano, Italia Pharma Point Srl A tempo pieno

OverviewFor a leading pharmaceutical company, Pharma Point is looking for aQuality Assurance Pharmacovigilance Specialist.The selected candidate will be responsible for ensuring the development, implementation, and maintenance of the company's Quality Management System in the area of Pharmacovigilance, in accordance with the quality standards of the Group.Key ResponsibilitiesManagement of Quality Assurance activities to ensure compliance with Good Pharmacovigilance Practices (GVP) and applicable regulationsManagement of SOPs / Work Instructions related to pharmacovigilance processesOversight and coordination of pharmacovigilance auditsQA review / approval of deviations, CAPAs, and change controls related to PV topicsSupport in the review and update of the Pharmacovigilance System Master FileRisk assessment management to prioritize audits (affiliates, partners, vendors, PV system)QualificationsPrevious experience in a similar role within pharmaceutical companies and / or PV CROsStrong understanding of Quality Assurance standardsWillingness to travel periodicallyFluent in English, both written and spoken#J-*****-Ljbffr

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