Amgen Global Safety Senior Scientist (Nurse) in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Global Safety Senior Scientist (Nurse)
What you will do
Let’s do this. Let’s 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.
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
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
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.
- 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
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.
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.