Amgen is seeking a Global Safety Senior Manager - Combination Products to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:
Amgen is a science-based biotechnology pioneer. Our innovative human therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve new patients.
Working under the supervision of the Head of Combination Product Safety (CPS), the Global Safety Senior Manager will be responsible for:
Other activities include:
•Contribute to assigned product SAT/ GST pharmacovigilance activities when they pertain to device, companion diagnostic and digital health safety, including single case assessment, aggregate data analysis, and risk management activities.
•Provide combination product safety expertise to protocol/ICF/CSR review and preparation of filing documents.
•Support responses to regulatory queries for safety information as required.
•Contribute to the establishment of processes/procedures and best practices related to device/combination product development and commercialization with respect to safety.
•Under supervision of CPS Head, conduct review of adverse event aggregate data in order to detect potential product/device quality issues.
•For assigned products, provide review of and input to device risk management documents, including hazard analysis, use risk assessments, human factors protocols and reports, etc.
•Under supervision of CPS Head, perform authoring of device/combination product system risk/benefit analyses
•Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
•Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Doctorate degree and 2 years of Safety experience
Master's degree and 6 years of Safety experience
Bachelor's degree and 8 years of Safety experience
Associate's degree & 10 years of Safety experience
High school diploma / GED & 12 years of Safety experience
• Demonstrated relevant scientific training OR
Clinical experience in activities relevant to utilization of medical devices, especially as related to combination products (nursing, study management, pharmacist, etc.)
• Very strong knowledge of clinical trial device safety monitoring regulations and standards
• Strong knowledge of device development and commercialization principles including but not limited to design controls, Quality Management Systems, and other relevant standards and regulations.
• Strong knowledge of device risk management methodology, standards, and tools
• Very strong knowledge of post market safety reporting regulations/best practices for devices/combination products globally.
• Basic knowledge of signal detection principles for drugs/biologics.
•Excellent interpersonal and teamwork skills.
•Critical scientific thinking and problem solving, attention to detail.
•Organizational savvy and ability to operate effectively in a matrix environment
•Prioritization and time management skills.
•Written Communications, oral presentation and medical writing skills.
•Conflict management skills.
•Working knowledge of Microsoft Suite (Outlook, Word, Excel, PowerPoint)