Senior Manager Triage
Core
Lead the triage of Individual Case Safety Reports (ICSRs) within Argus Safety, overseeing a team of healthcare professionals to ensure accurate case assessment, regulatory compliance, and inspection-ready documentation.
Role type
Senior Manager, Pharmacovigilance Triage Team Lead
Builds
Regulatory-compliant safety databases and inspection-ready documentation for global health authorities
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICH E2A/E2B/E2D guidelines knowledge, ICSR intake and processing, Argus Safety proficiency, expedited reporting logic, clinical judgment, MedDRA coding, structured summary authoring
Preferred skills
AI and GenAI integration in pharmacovigilance, triage or first-line safety review experience
Technologies
Argus Safety, AI, GenAI
Responsibilities
Perform medical triage of incoming ICSRs including assessment of seriousness, expectedness, and causality; Apply expedited vs. non-expedited reporting logic; Verify source completeness using standardized checklists; Assign cases to appropriate Argus workflows; Escalate complex cases to Lead Medical Reviewer; Author structured summaries for serious and high-risk cases; Maintain compliance with SOPs and inspection readiness requirements
Seniority
Senior Manager, hands-on IC with team leadership