Global Safety Senior Manager
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 support safety assessment activities for medical and scientific operations. This person will also provide scientific and compliance expertise to the Global Patient Safety (GPS) organization.
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
- Perform data analysis to evaluate safety signals and write up analysis results.
- Author safety assessment reports as well as other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
- Prepare and present the Global Safety Teams recommendations on safety issues to cross-functional decision-making bodies.
- Author and review portions of periodic aggregate safety reports (e.g. PBRERs, DSURs).
- Support clinical trial-related activities: provide support and oversight to staff with regards to safety in clinical trials; review and provide input and support on clinical trial-related documents (e.g. study protocols, statistical analysis plans, safety-related data collection forms, and the design of tables, figures, and listings for clinical trial safety data); review of adverse events or serious adverse events from clinical trials; and participate in study team meetings.
- Assist the GSO in the development of risk management strategies and activities: provide contents for risk management plans (RMPs); develop or update strategy and content for regional RMPs; assist the GSO in overseeing risk minimization activities including tracking of activities; evaluate risk minimization activities; and prepare responses to regulatory inquiries related to RMPs under the guidance of the GSO.
- Support activities related to new drug applications and other regulatory filings: assist the GSO in developing a strategy for safety-related regulatory activities; and provide safety contents for filings.
- Document work in the safety information management system.
- Organize and act as a direct liaison for safety activities with affiliates and other internal Amgen partners.
- Undertake activities delegated by the Qualified Person for PV as detailed in the PV system master file and maintain a state of inspection readiness.
- Represent and be the point of contact for health authority inspections and internal process audits within the remit of the role.
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The dedicated professional we seek is a partner with these qualifications.Basic Qualifications:
- Doctorate degree and 2 years of directly related experience Or
- Masters degree and 6 years of directly related experience Or
- Bachelors degree and 8 years of directly related experience Or
- Associates degree and 10 years of directly related experience Or
- High school diploma / GED and 12 years of directly related experience
- RN, PharmD, or PA
- 4 years of pharmacovigilance experience
- Experience in signal detection, evaluation and management
- Experience in aggregate data analysis, interpretation and synthesis
- Experience in authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs
- Clinical and/or medical research experience
- Previous management and/or mentoring experience
- Extensive knowledge of ICH guidelines, safety systems (e.g. ARISg and Argus) and MedDRA
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
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.
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.