Pharmacovigilance Specialist (1-Year Maternity Cover)
Core
Maintain an efficient local Pharmacovigilance system in the Nordic countries, ensuring compliance with European and national regulations and managing safety data for Baxter's healthcare products.
Role type
Pharmacovigilance Specialist (1-year maternity cover)
Builds
Local PV system and safety reporting infrastructure for the Nordics
Domain
Healthcare / Pharmaceutical / Pharmacovigilance
Required skills
ADR reporting, clinical trial safety processing, audit and inspection management, third-party agreement compliance, regulatory intelligence, literature review, procedure implementation, compliance monitoring
Preferred skills
Stakeholder management, cross-functional collaboration, training delivery
Technologies
GPS (Global Patient Safety), SOPs, local regulatory databases
Responsibilities
Collect, document, and transmit local Adverse Events (AEs) and other safety information to GPS; Process Serious Adverse Events (SAEs) from clinical trials; Act as local representative during audits and inspections; Collaborate with third parties to ensure PV clauses in agreements; Screen regulatory websites for safety signals and changes; Perform local literature reviews and risk minimization activities; Create and update local PV procedures; Monitor local compliance and resolve noncompliance reports; Collaborate with the UK cluster team on PV activities.
Seniority
Mid-level, hands-on IC