Amgen Global Safety Senior Manager Medical Reviewer in Cambridge, Massachusetts

Amgen is Seeking a Global Safety Senior Manager Medical Reviewer to work out of their Cambridge, MA or Thousand Oaks, CA location

The Global Safety Senior Manager Medical Reviewer provides medical review of serious and non-serious individual case safety reports in support of safety surveillance for Amgen products. To support global individual case safety regulatory reporting compliance.

Additional responsibilities of the Global Safety Senior Manager Medical Reviewer are:

  • To assure medical validity and provide input to the activities of Medical Safety Review Team

  • To execute the medical review of Individual Case Safety report's (ICSRs) (narratives, coding, expectedness, causality and seriousness) to ensure quality reports

  • To act as a significant point of contact between Case Managers and Global Safety Officer's (GSOs) on medical content and regulatory reporting of ICSRs

  • Execute medical triage for appropriate causality assessment on ICSRs and timely regulatory reporting

  • Execute appropriate case follow up per SOPs

  • Support medical coding conventions, data collection methods, and systematic process improvements for Adverse Event (AE) processing

  • Support training to Amgen employees on ICSR medical review

  • Mentor junior Global Patient Safety (GPS) medical reviewers

  • 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 case management

  • Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (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:

Doctorate degree and 2 years of drug safety experience

OR

Master's degree and 6 years of drug safety experience

OR

Bachelor's degree and 8 years of drug safety experience

OR

Associate's degree and 10 years of drug safety experience

OR

High school diploma / GED and 12 years of drug safety experience

Preferred Qualifications:

  • BSN, PharmD, DDS/DMD, PA, MD/DO or international equivalent; plus 3 years drug safety experience

  • Knowledge of case management regulatory requirements for pharmacovigilance

  • Clinical knowledge of therapeutic area patient populations and drug class

  • Proficiency in technical safety systems including the Argus Safety database and medical coding

  • Knowledge of safety data capture in clinical trials and in the post marketing environments

  • Knowledge of clinical trials and drug development

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.