Global Safety Sr Medical Scientist - Global Safety Physician
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 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 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
- Organize and direct liaison activities with affiliates and other internal Amgen partners regarding products
- Supports and provides oversight with regards to safety in clinical trials to
- 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
- 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
- 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
MD or equivalent degree from an accredited medical school
- 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
- Inflammation and nephrology knowledge
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 breakthrough potential.