Amgen Inc. is looking for a Global Pharmacovigilance (PV) Scientist to provide critical safety strategy and deliverables for our products, with a particular focus on the Immuno-oncology portfolio. You will join our collaborative, science-based culture dedicated to serving patients and collaborate closely with Global Safety Officers (GSO).
What You'll Do
- Contribute to planning, preparing, writing and reviewing periodic aggregate safety reports.
- Review adverse events and serious adverse events from clinical trials.
- Review and provide input on study protocols, statistical analysis plans, and other clinical study documents.
- Review standard design of tables, figures, and listings for safety data from clinical studies.
- Participate in developing safety-related data collection forms for clinical studies.
- Attend study team meetings as requested.
- Conduct signal detection, evaluation, and management.
- Perform data analysis to evaluate safety signals and write up analysis results with the GSO.
- Prepare safety assessment reports, other safety documents, and regulatory responses.
- Search and review adverse event data, literature, and other safety-relevant data for signal detection.
- Participate in Safety Governance per Amgen processes.
- Prepare presentations of the Global Safety Team’s recommendations to cross-functional decision-making bodies.
- Assist GSOs and Senior Scientists in developing risk management strategy and activities, including providing content for risk management plans.
- Update strategy and content for regional risk management plans.
- Assist GSOs in overseeing and evaluating risk minimization activities.
- Prepare responses to regulatory inquiries related to risk management plans under GSO guidance.
- Support activities for new drug applications and other regulatory filings.
- Assist in developing a strategy for safety-related regulatory activities and provide safety content for filings.
- Perform other related duties as defined in procedures or requested by your supervisor.
What We're Looking For
- Doctorate degree OR Master’s degree and 2 years of relevant experience OR Bachelor’s degree and 4 years of relevant experience.
Nice to Have
- Healthcare professional background.
- 1 year of drug safety/PV experience.
- Experience in signal detection, evaluation and management.
- Experience as a contributor to periodic aggregate safety reports.
- Experience with literature surveillance: source document review, knowledge, and skills.
- Experience with the Argus Safety database.
- Good clinical and scientific judgment.
- Clinical and/or medical research experience.
- Strong written and verbal communication skills.
Technical Stack
- Argus Safety database
Team & Environment
You will be part of a team of PV Scientists working in collaboration with Global Safety Officers (GSO).
Benefits & Compensation
- Annual base salary range of $122,105.00 - $145,799.00 USD.
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program.
- Stock-based long-term incentives.
- Award-winning time-off plans.
Work Mode
This role operates on a hybrid work model and is open to candidates in the U.S. (excluding Puerto Rico).
Amgen is an Equal Opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
