Amgen

Global Safety Senior Medical Scientist (Physician)

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 11, 2020
Ref
R-102182
Required Education
Bachelors Degree
Position Type
Full time
As the Global Safety Senior Medical Scientist, 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. Can be located in Thousand Oaks, or any US remote location, or other remote location.

The function

This Group's purpose is to provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products. To support global individual case safety reports 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


Key responsibilities include
  • 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


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

Basic Qualifications

Medical Qualification MD or international equivalent

Clinical and/or Drug Safety experience

Preferred Qualifications

MD/DO or international equivalent plus 3 years relevant work

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.