Amgen Global Safety Sr Mgr in Thousand Oaks, California
Amgen is seeking a Global Safety Sr Mgr. – Global Pharmacovigilance (PV) Senior Scientist to join our team and work from the Thousand Oak CA Headquarters or Amgen’s Cambridge, MA campus. Other locations may be considered. To learn more about this position:
The Global PV Senior Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise to Global Patient Safety (GPS).
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 GPS and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.
The Global PV Senior Scientist is responsible for the following:
Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
Perform data analysis to evaluate safety signals and write up analysis results.
Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
Direct the planning, preparation, writing and review of safety portions of aggregate reports.
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: Provide 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.
Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products.
Provide support for clinical trials to review and provide input to study-related documents (e.g., study protocols; statistical analysis plans; safety-related data collection forms; and design of tables, figures, and listings for safety data from clinical studies) and provide aggregate review of Adverse Events (AEs)/Serious Adverse Events (SAEs) from clinical trials.
Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (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.
Doctorate degree and 2 years of directly related experience OR
Master’s degree and 6 years directly related experience OR
Bachelor’s degree and 8 years of directly related experience OR
• RN, PharmD, MPH or PA
• Three to five years direct experience in pharmacovigilance: signal detection and evaluation; data analysis interpretation and synthesis; periodic report production
• Knowledge of processes and regulations for pharmacovigilance and risk management
• Clinical/medical research experience
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.