Medical Evaluator - Global Case Management
Core
Oversee vendor activities and provide guidance on complex medical evaluations to ensure high-quality Individual Case Safety Reports (ICSRs) and compliance with pharmacovigilance regulations.
Role type
Senior Medical Evaluation Manager (Pharmacovigilance)
Builds
High-quality, timely medical evaluations and Individual Case Safety Reports (ICSRs)
Domain
Life Sciences / Pharmacovigilance
Required skills
Medical/Pharmacy degree (MD/PharmD), 7+ years PV industry experience, causality assessment, ICSR management, regulatory compliance, vendor oversight, complex biologic assessment
Preferred skills
Experience with vaccines and combination products, risk management initiatives
Technologies
CIOMS, AE grading and coding conventions
Responsibilities
Oversee vendor medical evaluation activities; Apply medical judgment to assess safety information (causality, expectedness, seriousness); Ensure compliance with PV regulations and SOPs; Contribute to process improvement; Deliver onboarding training to vendor evaluators; Monitor vendor performance and workload; Respond to health authority queries; Interface with stakeholders and approve regulatory reports
Seniority
Senior, hands-on IC with leadership responsibilities