Key contributor in Integrated Resource Planning at Duke Energy. Prepare executives for regulatory testimonies on future energy demands and regulatory compliance.
About the role
- 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
- Fluency in written and verbal English
Benefits
- Flexibility
- Professional development opportunities
- Equal Employment Opportunity
- Disability Inclusion
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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