Global Safety Sr Mgr- Global Pharmacovigilance Senior Scientist

Amgen is seeking a Global Safety Sr Mgr. - Global Pharmacovigilance (PV) Senior Scientist to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. 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).
• 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 (egg, 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.
• Aggregate 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.

Basic Qualifications

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

Associate's degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly related experience

Preferred Qualifications

• 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 provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs 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.

Join Us

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.

Join Us

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.