Global PV Scientist (Safety Manager)

Thousand Oaks, CA, US
Dec 03, 2020
Required Education
Bachelors Degree
Position Type
Full time
Amgen is searching for a Global Pharmacovigilance Scientist (Global Safety Manager) to work in either our Thousand Oaks, CA location or our Cambridge, MA location. The Global PV Scientist will report to the Global Safety Director.

The Global PV Scientist works with the Therapeutic Area Safety Teams, performing safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise to the Global Patient Safety and Pediatrics (GPS&P) organization.

The PV Scientist is responsible for the following:

o Contributes to the planning, preparation, writing and review of periodic aggregate safety reports.

o Works with affiliates and other internal Amgen partners regarding deliverables.

o Review of adverse events and serious adverse events from clinical trials.

o Review and provide input and support on study protocols, statistical analysis plans and other

clinical study-related documents.

o Review standard design of tables, figures, and listings for safety data from clinical studies.

o Participate in development of safety-related data collection forms for clinical studies.

o Attend study team meetings as requested.

o Conduct signal detection, evaluation, and management.

o Perform data analysis to evaluate safety signals and write up analysis results in collaboration

with the Global Safety Officer (GSO).

o Prepare safety assessment reports and other safety documents and regulatory responses.

o Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.

o Participates in Safety Governance per Amgen processes.

o Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making bodies.

o Assist GSOs and other Senior PV Scientists in the development of risk management strategy and activities.

o Provides contents for risk management plans.

o Update strategy and content for regional risk management plans.

o Assist GSOs to oversee risk minimization activities including tracking of activities.

o Evaluate risk minimization activities.

o Prepare response to regulatory inquiries related to risk management plans under the guidance of the GSO.

o Support activities related to new drug applications and other regulatory filings.

o Assist GSOs and other Senior PV Scientists in developing a strategy for safety-related regulatory activities.

o Provide safety contents for filings.

o Performs other duties related to the position as defined in Standard Operating Procedures or as requested by his/her supervisor.

o Undertake activities delegated by the Qualified Person For PV (QPPV) as detailed in the PV

System Master File and maintains a state of inspection readiness.

o Be the representative and point of contact for Health Authority Inspections and Internal Process Audits within the remit of role and responsibility.

o Contribute to the development, improvement, and standardization of PV processes and methods.

o Participates on teams for the implementation of new processes and methods within the Therapeutic Area.

Basic Qualifications:

Doctorate degree


Master's degree and 3 years of scientific experience


Bachelor's degree and 5 years of scientific experience


Associate's degree and 10 years of scientific experience


High school diploma / GED and 12 years of scientific experience

Preferred Qualifications:

o Bachelor of Science degree

o Health care professional background

o 1 year of drug safety/PV experience

o Experience in signal detection, evaluation and management

o Experience as a contributor to periodic aggregate safety reports

o Experience with literature surveillance: source document review, knowledge, and skills

o Experience with the Argus Safety database

o Good clinical and scientific judgment

o Clinical and/or medical research experience

o Strong written and verbal communication skills

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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 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.

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.