Associate Director, Triage and Medical Review
Core
Lead triage and medical review of Individual Case Safety Reports (ICSRs) for global development programs and marketed products, ensuring quality and alignment with pharmacovigilance standards.
Role type
Associate Director, Triage and Medical Review Team Lead
Builds
Comprehensive case documentation for regulatory submissions
Domain
Pharmacovigilance / Life Sciences
Deliverable
client delivery
Required skills
ICH E2A/E2B/E2D guidelines, ICSR medical review, narrative authoring, causality assessment, expectedness determination, Argus Safety, MedDRA coding, clinical judgment
Preferred skills
Global development program support, insourced PV model experience, AI technologies in PV
Technologies
Argus Safety, MedDRA
Responsibilities
Oversee complete medical review of ICSRs and ensure accurate data capture in Argus; Lead and harmonize triage team activities; Develop innovative approaches integrating new technologies like AI; Review and update case narratives and causality rationale; Provide guidance on expectedness determinations; Oversee MedDRA coding of adverse events; Collaborate across teams for regulatory submissions; Support SOP development and inspection readiness.
Seniority
Senior, hands-on IC with team leadership