Job Description
Position Purpose
The QPPV Compliance Director supports the activities of European Union Qualified Person for Pharmacovigilance (EUQPPV) and the European Safety Office and guarantees the oversight of the quality and compliance of the Pharmacovigilance system.
Primary Responsibilities
• Establishment of a monitoring system to ensure evolving local requirements are reflected in the local QPPVs activities and in the global PV system
• Collaboration with SQ as regards the establishment and maintenance of PSMFs where required and the support in case of PV inspections of those countries/regions where a QPPV is required
• Collaborates with PV Licensing Team, for all external partnerships (inbound or outbound) for the development, marketing, promotion or distribution of Pfizer medicinal/device products for human, and their alignment with regulatory requirements
• Quality and compliance interface with partner lines and other stakeholders.
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