Pharmacovigilance Officer - DEMO Global Services
Core
Perform global literature screening, review, assess, process, and record Individual Case Safety Reports (ICSRs) for a diverse portfolio of medicinal products.
Role type
Pharmacovigilance Officer
Builds
Safety information handling and regulatory compliance for medicinal products
Domain
Pharmaceutical industry / Pharmacovigilance
Deliverable
client delivery
Required skills
Global literature screening, ICSR processing, EudraVigilance management, XEVMPD maintenance, regulatory compliance documentation
Preferred skills
Pharmacovigilance database experience, Microsoft Office proficiency
Responsibilities
Perform global literature screening and review in accordance with GVP requirements; Review, assess, process, and accurately record Individual Case Safety Reports (ICSRs); Conduct routine review and management of ICSRs received from MHRA and EMA; Maintain and update the EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD); Ensure timely and compliant handling of safety information; Maintain accurate documentation to support regulatory compliance.
