Safety and Medical Process Excellence Manager

2 days ago


Hartford, Connecticut, United States Amgen Full time
As a Safety and Medical Quality Lead-Observational Research at Amgen, you will play a pivotal role in shaping the future of biotechnology and pharmaceuticals. With a strong focus on Observational research activities, this position requires a seasoned professional with a deep understanding of Good Pharmacovigilance Practice (GPvP) and Good Clinical Practice (GCP). Your exceptional leadership skills, combined with your auditing expertise and knowledge of global regulatory requirements, make you an ideal candidate for this challenging role.

The successful candidate will lead the pharmacovigilance (GPvP) annual audit plan, prepare and complete audits, investigate and supervise Quality events, and support partner audits and regulatory inspections. You will also provide Quality input for processes relating to Observational research studies, including the clinical trial risk assessment (CT-RACT), and participate in due diligence activities for potential business development opportunities. Additionally, you will ensure proactive identification of issues relating to processes, programs, and external relationships, escalate issues to appropriate compliance/quality oversight bodies, and participate in compliance investigations, management, and remediation.

We are seeking a highly skilled and experienced professional who can demonstrate a proven track record with auditing, preferably in GPvP or GCP, and knowledge of global regulatory requirements. You should also possess some knowledge of statistical programming used with observational research, such as STATA or SAS, and experience and knowledge of requirements for computer systems audits. Excellent time management skills, the ability to handle competing priorities, and exceptional oral and written communication and writing skills are essential for this role. If you have a degree qualification, 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, we encourage you to apply for this exciting opportunity.

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