Pharmaceutical Safety Leader
1 week ago
About the Company:
Amgen SA is one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Our shared mission—to serve patients—has driven our status as a leader in the industry.
Job Description:
We are seeking a Clinical Quality and Safety Manager to support our Safety and Medical processes, with a focus on Observational research activities. The successful candidate will identify compliance issues, participate in audits, quality investigations, and remediation activities. Key responsibilities include supporting the pharmacovigilance (GPvP) annual audit plan, preparing and completing audits, investigating Quality events, and assisting with partner audits and regulatory inspections.
Responsibilities:
- Support the completion of the audit plan for GPvP suppliers/vendors and processes
- Investigate Quality events, and assist with partner audits and regulatory inspections
- Support GxP audits from business partners, GxP inspection readiness and inspection management activities
- Support R&D Quality governance in clinical development, pharmacovigilance and/or observational research
- Collate compliance metrics for presentations to key stakeholders
- Support vendor evaluations related to observational research studies and GPvP or GCP vendors
Requirements:
A degree education, proven experience in the Pharma/Biotech sector, and experience as an auditor, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP), are required. A solid understanding of global regulatory requirements for GPvP/GCP/observational research is also required. Experience in supporting GPvP/GCP audits or inspections, outstanding oral and written communication skills, and some knowledge of statistical programming tools are desirable. This is a highly competitive position with an estimated salary range of $150,000 - $220,000 per year, depending on experience and qualifications.
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