Medical Reviewer
Core
Provide medical and operational oversight for end-to-end medical review activities supporting global pharmacovigilance, including ICSR medical assessment and submission readiness.
Role type
Senior IC Medical Reviewer (Pharmacovigilance)
Builds
Inspection-ready safety databases and regulatory submissions for pharmaceutical clients
Domain
Healthcare / Pharmacovigilance / Drug Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICSR medical assessment, MedDRA coding, WHO Drug coding, operational oversight, vendor management, regulatory compliance, safety surveillance support, process development, cross-functional leadership
Preferred skills
Experience leading cross-functional processes, developing PV standards and training materials, managing multi-year roadmaps, transformation automation initiatives
Technologies
MedDRA, WHO Drug
Responsibilities
Provide medical review and assessment for ICSRs with focus on high-interest cases; oversee ICSR coding standards and conventions; support Benefit-Risk activities and safety strategy; act as SME during internal audits and regulatory inspections; provide operational management and oversight of the medical review model; partner with PV Operations leadership on strategy and automation initiatives
Seniority
Senior, hands-on IC with operational leadership