Amgen Global Safety Senior Medical Scientist – Global Safety Physician in Thousand Oaks, California
Amgen is seeking a Global Safety Physician 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 signals, risk management activities, and benefit risk assessments for an assigned set of products. The Global Safety Physician will report to 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 are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.
The Global Safety Physician is responsible for the following:
Directs the planning, preparation, writing and review of portions of aggregate reports
Perform Signal detection, evaluation, and management
Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO and Pharmacovigilance scientist
Supports and provides oversight with regards to safety in clinical trials
Review and provide input on study protocols, statistical analysis plans, provide safety contents for regulatory filings. Reviews safety tables, figures, and listings from clinical studies.
Support activities related to new drug applications and other regulatory filings
Prepare presentations to the Global Safety Team on safety issues
Assist GSO in the development of risk management strategy and activities, and safety-related regulatory activities
Organize and direct liaison activities with affiliates and other internal Amgen partners regarding products
Additional duties as assigned
MD or equivalent degree from an accredited medical school
1-2 years experience working within Pharmacovigilance/Safety functions
Working knowledge of global drug development and pharmacovigilance guidelines and regulations
Ability to work independently, to manage stress, and to adapt in a fast-changing business environment
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Clinical/medical research experience
Experience in Oncology, Bone or Metabolic therapeutic area
Knowledge of relevant concepts in epidemiology and statistics;
Effectively communicates in written and spoken English
Detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
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.
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.