Amgen Global Safety Sr Mgr in Cambridge, Massachusetts
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).
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.
Directs the planning, preparation, writing and review of safety portions of aggregate reports.
Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products.
Supports and provides oversight to staff with regards to safety in clinical trials to review and provide input and support on clinical study-related documents (eg, study protocols; statistical analysis plans; safety-related data collection forms; and design of tables, figures, and listings for safety data from clinical studies) and participate in study team meetings.
Review of Adverse Events (AEs)/Serious Adverse Events (SAEs) from clinical trials.
Documents work in the safety information management system.
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 Safety experience in a Pharmaceutical or Biotech Industry
Master's degree and 6 years Safety experience in a Pharmaceutical or Biotech Industry
Bachelor's degree and 8 years of Safety experience in a Pharmaceutical or Biotech Industry
Associate's degree and 10 years of Safety experience in a Pharmaceutical or Biotech Industry
High school diploma / GED and 12 years of Safety experience in a Pharmaceutical or Biotech Industry
RN, PharmD or PA
Clinical/medical research experience
Processes and regulations for pharmacovigilance and risk management
Aggregate data analysis, interpretation and synthesis
Signal detection, evaluation and management
6+ years of experience in a biotech/pharmaceutical setting
Previous management and/or mentoring experience
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.