Global Safety Sr Medical Scientist
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 Sr Medical ScientistLive
What you will do
Lets do this. Lets change the world. In this vital role you will serve as the medical expert for the team to support the Global Safety Officer in the management of safety signal, risk management activities, and benefit risk assessments for an assigned set of products.
- Signal detection, evaluation, and management - performs data analysis to evaluate safety signals and authors analysis results for Safety Assessment Reports in collaboration with the GSO
- Supports and reviews safety data in clinical trials, study protocols, statistical analysis plans and other clinical study-related documents; review of AEs/SAEs from clinical trials as needed; reviews standard design of tables, figures, and listings for safety data from clinical studies; participates in development of safety-related data collection forms for clinical studies and participates in study team meetings as requested or needed
- Directs the planning, preparation, writing and review of portions of aggregate reports
- Organizes and directs liaison activities with affiliates and other internal Amgen partner regarding products
- Authors various safety documents and health authority responses in collaboration with the GSO
- Searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Prepares and presents Global Patient Safetys recommendations on safety issues to the cross-functional decision-making body
- Assists GSO in the development of risk management strategy and activities
- Supports activities related to new drug applications and other regulatory findings Inspection readiness - undertakes activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
- Be the 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 go-getter with these qualifications.Basic Qualifications
- MD, DO or medical degree from an accredited medical school AND 2+ years of work experience
- Completion of an accredited medical or surgical residency
- clinical experience in either an accredited academic setting or private practice (including hospital based) setting
- Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
- Clinical/medical research experience
- Product safety in the bio/pharmaceutical industry
- Previous management and or mentoring experience
- Experience in leading teams and or projects
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.