Global Safety Senior Medical Scientist (Physician)
HOW MIGHT YOU DEFY IMAGINATION?
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 Medical Scientist (Physician)Live
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 individual case safety reports in support of safety surveillance for Amgen products. You will also support global individual case safety report regulatory reporting compliance.Job Summary
- To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)
- To execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
- To act as a significant point of contact between Case Management and GSOs (Global Safety Officers) on medical content and regulatory reporting of ICSRs
- Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
- Act as MSRT product lead and/or therapeutic area lead as assigned
- Execute ICSR case escalation to GSO as appropriate
- Execute appropriate case follow up per SOPs
- Support medical coding conventions, and systematic process improvements for ICSR medical review
- Maintain list of expected terms in the auto label tool
- Support training to Amgen employees on ICSR medical review
- Mentor junior GPS medical reviewers. As needed and applicable, provide direct managerial responsibilities for medical reviewers on his/her therapeutic or functional team
- Participate in Safety Assessment Team (SAT)
- Conduct reportability assessment for medical device complaints/malfunctions and review for potential product problems.
- Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review
- Performs other duties related to the position as necessary as defined in SOPs 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 dynamic professional we seek is a leader with these qualifications.Basic Qualifications
- Medical Qualification MD or international equivalent
- Clinical and/or Drug Safety experience
- MD/DO or international equivalent plus 3 years relevant work
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.
careers.amgen.comEqual 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 UsIf 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.