Global Safety Sr Mgr (Open to 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 work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise to Global Patient Safety (GPS).
- 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 and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
- Direct the planning, preparation, writing and review of safety portions of aggregate reports.
- Prepare presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making body.
- Assist GSO in the development of risk management strategy and activities: Provide contents for risk management plans; Develop or update strategy and content for regional risk management plans;
- Assist GSOs to oversee risk minimization activities including tracking of activities; Evaluate risk minimization activity; Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO.
- Support activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities; Provide safety contents for filings.
- Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products.
- Provide support for clinical trials to review and provide input to study-related documents (e.g., study protocols; statistical analysis plans; safety-related data collection forms; and design of tables, figures, and listings for safety data from clinical studies) and provide aggregate review of Adverse Events (AEs)/Serious Adverse Events (SAEs) from clinical trials.
- Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness.
- Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The 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 directly related experience OR
- Bachelors degree and 8 years of directly related experience
- RN, PharmD, MPH or PA
- Three to five years direct experience in pharmacovigilance: signal detection and evaluation; data analysis interpretation and synthesis; periodic report production
- Knowledge of processes and regulations for pharmacovigilance and risk management
- Clinical/medical research experience
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.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.