Beschreibung
Wir, die Accessio IMS, suchen ab Mitte Juni 2020 für unseren internationalen Kunden einen Interim Pharmacovigilance Consultant (w/m/d) für ca. 3 Monate am Standort Raum Darmstadt.PV System and QPPV Support:
The role is responsible for the management of all patient safety-related activities concerning QPPV Office tasks, support of PV audits and inspection and PV System improvements projects. This includes:
• contributing to update and enhancemenrt of Pharmacovigilance System Master File and local PSMFs projects
• Coordinating all pharmacovigilance-related activities in inspections and audit preparation
• Ensuring writing and timely delivery of responses to the inspection/audit report (Corrective and Preventive Action Plan)
• Responsibility for oversight on documentation of all inspections/audits including corrective and/or preventive actions, following-up with concerned
functions as well as maintaining filing of inspection/audit key documentation, including evidence of completed actions.
• Support to Patient Safety affiliate staff before, during and after inspections/audits conducted at affiliate
• Contributing to PV process improvements, leading improvement activities
• Ensuring that identified compliance and quality issues with the pharmacovigilance system are addressed
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