Global Safety Senior Manager - Combination Products, US- Remote
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Global Safety Senior ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will be part of the combination product global safety team ensuring the excellence of Amgen products for the portfolio.
As the Global Safety Senior Manager within the Combination Products group you will be responsible for:
- Assessing potential impact of quality findings on patient/user safety for all clinical and commercial products in conjunction with members of the Global Safety Team
- Providing consultation to Therapeutic Area Safety for the review of adverse event data to detect potential product quality issues for commercial products
- Providing consultation for device/combination product safety data collection/analysis/reporting
- Providing expertise for device/combination product risk management activities
Other activities include:
- Contribute to assigned product Safety Advisory Team/ Global Safety Team 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.
- 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.
- 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 responsibilityWin
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
The safety professional we seek is a collaborative partner with these qualifications.
Doctorate degree and 2 years ofsafety experience
Masters degree and 6 years of safety experience
Bachelors degree and 8 years ofsafety experience
Associates degree and 10 years of safety experience
High school diploma / GED and 12 years ofsafety 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)
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.