Manager Triage
Core
First medical point of contact for Individual Case Safety Reports, assessing seriousness, expectedness, and causality to guide cases into regulatory workflows.
Role type
Senior IC medical triage manager (pharmacovigilance)
Builds
Prioritized safety case workflows and inspection-ready documentation for global patient safety
Domain
Healthcare / Pharmacovigilance
Required skills
Medical triage decision-making, ICH E2A/E2B/E2D guidelines, expedited/non-expedited reporting logic, Oracle Argus Safety, Reference Safety Information interpretation, MedDRA terminology, AI tool familiarity, SOP compliance, data privacy
Preferred skills
Generative AI in safety operations, high-volume case processing, process improvement via quality metrics
Responsibilities
Perform first-pass medical review of incoming Individual Case Safety Reports, Make independent medical triage decisions for routine, complex, and ambiguous cases, Apply expedited and non-expedited reporting logic, Verify source completeness using standardized intake criteria, Route cases to the appropriate safety workflow, Author concise preliminary case summaries for serious and high-risk cases
Seniority
Senior, hands-on IC