Pharmacovigilance and Medical Quality Director
6 days ago
About the Role:
We are seeking a highly experienced Pharmacovigilance and Medical Quality Director to lead our Safety and Medical Quality team in the UK. This role involves identifying and escalating compliance issues, participating in quality investigations, management, and remediation.
About Amgen:
At Amgen, we strive to be at the forefront of biotechnology, pushing the boundaries of what is possible to improve people's lives. Our R&D Quality organization is responsible for strengthening and enhancing our R&D Quality Management System, providing Quality oversight on R&D processes, and leading activities related to PV regulatory inspections and external audits.
Key Responsibilities:
- Develop and implement a comprehensive Quality Management System for Observational research studies, ensuring adherence to global regulatory requirements and industry best practices.
- Lead the pharmacovigilance (GPvP) annual audit plan, preparing and completing audits, investigating and supervising Quality events, and supporting partner audits and regulatory inspections.
- Collaborate with cross-functional teams to evaluate, qualify, and provide oversight of Pharmacovigilance vendors.
Requirements:
- Degree Educated
- Proven experience in R&D, Operations and/or Quality experience in the Pharma/Biotech sector
- Demonstrated leadership expertise in developing teams, coordinating projects or programs, and advising resource allocation
- Proven track record with auditing, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP) and knowledge of global regulatory requirements
Estimated Salary:
$140,000 - $200,000 per annum, depending on experience.
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