Global Safety Senior Scientist (Nurse)

Thousand Oaks, CA
Jun 04, 2021
Required Education
Bachelors Degree
Position Type
Full time


If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Global Safety Senior Scientist (Nurse)


What you will do

Lets do this. Lets change the world. In this vital role you will be part of a group whose purpose is to provide medical review of serious and non-serious individual case safety reports in support of safety surveillance for Amgen products. You will also support global individual case safety regulatory reporting compliance.

Primary Responsibilities
  • To assure medical validity and provide input to the activities of Medical Safety Review Team
  • To execute the medical review of ICSRs (individual case safety reports) (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
  • To act as a significant point of contact between Case Managers and GSOs on medical content and regulatory reporting of ICSRs

Key Activities
  • Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality and accurate reports
  • Execute the medical review of product complaints and potential product quality problems, and assess the need for safety quality investigations
  • Execute ICSR case escalation to GSO as appropriate
  • Execute appropriate case follow up per SOPs
  • Support medical coding conventions, data collection methods, and systematic process improvements for AE processing
  • Support training to Amgen employees/vendor on ICSR medical review and assessment of safety quality investigations
  • Mentor junior GPS medical reviewers. As needed and applicable, provide direct managerial responsibilities for medical reviewers on his/her therapeutic team
  • Participate in Safety Analysis Team (SAT)
  • Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including, process improvement standards development, SOP/MAN creation, and metrics with regards to medical review and combination product safety management
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Inspection Readiness
  • Undertake activities delegated by the QPPV as detailed in the 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


What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a partner with these qualifications.

Basic Qualifications
  • Clinical Nursing qualification and 3 years of related drug safety experience

  • Knowledge of, and ability to apply, US and International safety data collection and reporting requirements for drugs, combination products and medical devices
  • Working knowledge in reviewing and assessing ICSRs and product complaint reports and identifying potential product quality problems


What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request an accommodation.

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.