Amgen Global Pharmacovigilance Scientist (Global Safety Manager) in Cambridge, Massachusetts

Amgen is seeking a Global Safety Manager to function as a Global Pharmacovigilance (PV) Scientist at its Cambridge, MA location to join the Global Patient Safety & Labeling (GPS&L) group. The Global PV Scientist will report to the Global Safety Director.

The Global PV Scientist works with the Therapeutic Area Safety Teams, which 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. The Global PV Scientist contributes to safety assessment activities for medical/scientific operations and provides scientific and compliance expertise as needed to GPS&L.

Key Activities for the Global Safety Manager include:

  • Contributes to the planning, preparation, writing and review of safety portions of aggregate reports

  • Review of adverse events and serious adverse events from clinical trials as needed

  • Contributes under the direction of the Global PV Sr. Scientist or Lead to:

  • 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 in collaboration with Global Safety Officer

  • Prepare safety assessment reports and other safety documents and regulatory responses

  • Participate in Safety Governance per Amgen processes

  • Assist Global Safety Officer in the development of risk management strategy and activities

  • Review and provide input and support on clinical study-related documents (eg, study protocols; statistical analysis plans; and design of tables, figures, and listings for safety data from clinical studies) and attend study team meetings as requested or needed

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of biotech or pharmaceutical experience

OR

Bachelor's degree and 5 years of biotech or pharmaceutical experience

OR

Associate's degree and 10 years of biotech or pharmaceutical experience

OR

High school diploma / GED and 12 years of biotech or pharmaceutical experience

Preferred Qualifications

  • BS or BA in Life Science

  • 1+ year Drug Safety Experience

  • Experience in Signal detection, evaluation and management

  • Experience as a contributor to periodic safety reports

  • Good clinical and scientific judgment

  • Clinical and/or medical research experience

  • Excellent written and oral communication skills

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.

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.