Consultaning Pharmacovigilance

* Contributing to update and enhancement 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

VORAUSSETZUNGEN:

* Strong skills: Update and enhancemenrt of Pharmacovigilance System Master File and local PSMFs projects
* Experienced in coordinating all pharmacovigilance-related activities in inspections and audit preparation
* Strong skills: Corrective and Preventive Action Plan
* Strong skills: PV process improvements, leading improvement activities
* Good skills: Documentation of inspections/audits
* Experienced in compliance and quality issues with the pharmacovigilance system
* Very strong English skills, German skills are nice to have