Global Safety Senior Medical Scientist (Physician) – Oncology

Category: Safety
Job ID: R-69263
Employment Type: Full time
Location: US – California – Thousand Oaks
Posted Date: January 9, 2019

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

As a full-scale biotechnology company, Amgen integrates the nimble and innovative culture of a small biotech with the stability, heritage and experience of a large pharmaceutical company. For nearly four decades, we have been at the forefront of providing the oncology and hematology communities with novel therapies that have changed patients’ lives. Our portfolio, as a whole, ranks above industry average in terms of the number of first-in-class medicines we have brought to market, with two-thirds of our medicines gaining this distinction versus the industry average of one-third. We have pioneered five first-in-class oncology and hematology medicines including, Neupogen®, Nplate®, XGEVA®, BLINCYTO® and IMLYGIC®.

In our mission to serve patients, speed is absolutely critical. We’re rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team – working toward our mission of advancing high potential programs for cancer patients around the world.

As the Global Safety Senior Medical Scientist for Oncology, 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.

Job Summary:

  • To assure medical validity and provide input to the activities of Medical Safety Review Team
  • 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 Managers 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
  • Execute medical triage for appropriate causality assessment on ICSRs and timely regulatory reporting
  • 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 on ICSR medical review
  • Mentor junior GPS medical reviewers
  • Participate in 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 case 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

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

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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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.

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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.

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