QPPV Compliance Director supporting pharmacovigilance system quality and compliance at Pfizer. Collaborating with teams to meet regulatory requirements in international settings.
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 for the development, marketing, promotion or distribution of Pfizer medicinal/device products for human, and their alignment with regulatory requirements
WMS Inspection Readiness; support to the preparation for and to the conduct of internal or external audits and regulatory inspections of the PV system and its components globally
Ensure that policies and procedures are in place and maintained to guarantee quality and timeliness of deliverables
Requirements
PharmD certification or equivalent scientific degrees
At least 15 years of relevant experience in the pharmaceutical industry in pharmacovigilance or clinical research departments on an international level
Good understanding of computer technology, and management of relational database systems
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