15 days old

Global Safety Physician - Hematology/Oncology

Thousand Oaks, CA 91360
  • Job Code

Job ID: R-97231
Location: Thousand Oaks, CA, US 91360
Additional Location: US - California - South San Francisco, US - Massachusetts - Cambridge

Amgen is seeking a Global Safety Physician at its main headquarters in Thousand Oaks, CA to join the GPS-TAS (Global Patient Safety - Therapeutic Areas) organization and 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.

The Global Safety Physician will report to either a Global Safety Officer (GSO) or the Executive Medical Director Global Patient Safety and will be responsible for the conduct of safety monitoring and accountable for executing product related safety decisions and deliverables for assigned products as designated by GSO or TAH (Therapeutic Area Head). The Global Safety Officer may delegate to the Global Safety Physician. The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product from early clinical development to marketed products. Leaders in the therapeutic area safety teams support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

Key responsibilities of the Global Safety Physician:
  • Directs the planning, preparation, writing and review of safety sections of aggregate reports
  • Reviews and provides input on study protocols, statistical analysis plans, safety contents for regulatory filings
  • Reviews safety tables, figures and listings from clinical studies
  • Supports activities related to new drug applications and other regulatory filings
  • Performs signal detection, evaluation and management
  • Authors Safety Assessment Reports and responses to regulatory authority requests in collaboration with the GSO
  • Prepares presentations to the Global Safety Team
  • Assist GSO in the development of risk management strategy and activities
  • Additional duties as assigned

Basic Qualifications

MD or equivalent degree from an accredited medical school

Preferred Qualifications
  • Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
  • Clinical/medical research experience
  • Experience in a medical safety role in the bio/pharmaceutical industry

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Join Us

If 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.



Posted: 2020-05-16 Expires: 2020-06-16

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Global Safety Physician - Hematology/Oncology

Thousand Oaks, CA 91360

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