Job Description

• • 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 as assigned.
  • Execute ICSR case escalation 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 Quality Assurance of ICSR medical review.
  • Participate in Safety Assessment Team (SAT) (if applicable).
  • Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems.

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