Global Safety Senior Medical Scientist
Amgen is seeking a Global Safety Sr Medical Scientist to function as a Global Safety Physician (GSP) in its main headquarters in Thousand Oaks, CA to join Global Patient Safety (GPS) organization and serve as the medical expert of the team to support the Global Safety Officer (GSO) in the conduct of quality safety assessment and risk management processes and activities for an assigned set of products through the product's life cycle.
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. 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 GSP is responsible for the conduct of safety monitoring and accountable for executing all product related safety decisions and deliverables for assigned products as designated by GSO or Therapeutic Area Head (TAH). Global Safety Officer may delegate to the Global Safety Physician where medical input is needed.
Applicable tasks may vary by product(s) assigned and are performed under the supervision of the GSO. 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 partner regarding products
- Supports and provides oversight with regards to safety in clinical trials to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
- Review of AEs/SAEs from clinical trials
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Participate in development of safety-related data collection forms for clinical studies
- Participate in study team meetings as requested
- Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
- Documents work as required in the safety information management system
- Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection for clinical trials and postmarketing safety
- Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body
- Assist GSO in the development of risk management strategy and activities: Provides 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
- Inspection Readiness
- Undertake activities delegated by the QPPV as detailed in the 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
MD or DO degree from an accredited medical school
- Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
- Clinical/medical research experience
- Product safety experience in the bio/pharmaceutical industry
- Previous management and or mentoring experience
- Experience in leading teams and or projects
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.