Senior Pharmacovigilance (PV) Clinical Scientist
Core
Lead clinical review and medical evaluation of Individual Case Safety Reports (ICSRs) to ensure regulatory compliance and patient safety.
Role type
Senior Pharmacovigilance Clinical Scientist
Builds
Regulatory submissions and global safety database integrity
Domain
Biopharmaceuticals / Pharmacovigilance
Required skills
Clinical acumen, Adverse event evaluation, Causality assessment, Regulatory compliance (FDA/EMA/ICH), Vendor oversight, SOP authorship, Audit readiness
Preferred skills
Health Authority submission management, Global safety database expertise (Argus/ARISg), Inspection framework familiarity, Lean/Six Sigma process improvement
Technologies
Argus, ARISg
Responsibilities
Lead clinical review and medical evaluation of ICSRs; Perform clinical data entry and oversight in global safety databases; Drive regulatory submission excellence; Direct cross-functional vendor oversight initiatives; Lead continuous quality improvement initiatives; Oversee Technical and Medical Product Complaints; Serve as Patient Safety SME during audits and inspections
Seniority
Senior, hands-on IC