Safety Physician (Client-dedicated), Bulgaria, Serbia
Core
Provides medical and operational oversight for end-to-end medical review activities supporting global pharmacovigilance, including ICSR medical assessment and submission readiness.
Role type
Safety Physician (Pharmacovigilance)
Builds
Inspection-ready pharmacovigilance activities and medical review operating models
Domain
Life Sciences / Pharmaceutical Industry / Drug Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICSR medical review, pharmacovigilance regulations, MedDRA coding, WHO Drug coding, operational oversight, cross-functional process leadership, vendor management, risk assessment, analytical skills
Preferred skills
Experience in operational oversight, leading cross-functional processes, vendor oversight, performance monitoring
Technologies
MedDRA, WHO Drug
Responsibilities
Provide medical review and assessment for ICSRs, lead supplemental medical review of key cases, perform targeted off-line quality control, engage with medical affairs and vendors for complex cases, oversee ICSR coding standards, contribute to PV standards and training materials, support Benefit-Risk activities, act as SME during audits and inspections, monitor operational and quality metrics
Seniority
Mid-level, hands-on IC