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Medical Safety Reviewer

Thousand Oaks, CA
Day to Day Responsibilities:
  • To provide medical review of individual safety case reports (ICSR) and or ICSRs for products with an established safety profile in support of safety surveillance for Amgen products.
  • To support global individual case safety regulatory reporting compliance.
Summary:
  • To provide medical review of individual safety case reports (ICSR) and or ICSRs for products with an established safety profile in support of safety surveillance for Amgen products.
  • To support global individual case safety regulatory reporting compliance.
  • 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 Senior Medical Reviewer as appropriate
  • Execute appropriate case follow up per SOPs
  • Support medical coding conventions, data collection methods, and systematic process improvements for AE processing
  • Participate in SAT as requested
  • Conducts report ability assessment for device complaints/malfunctions.
  • 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
"This posting is for Contingent Worker, not an FTE"
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