Global PV Risk Management Partner
Core
Lead the development and maintenance of Pharmacovigilance Risk Management Plans (PV-RMPs) to ensure the safe use of Baxter products worldwide.
Role type
Senior Pharmacovigilance Risk Management Specialist
Builds
Global PV-RMPs and associated risk management commitments
Domain
Healthcare / Pharmacovigilance
Required skills
PV-RMP authoring, regulatory submission management, cross-functional coordination, project management, risk minimization strategy, regulatory authority interaction, technical writing, critical thinking, analytical skills
Preferred skills
Advanced degree, clinical practice experience, non-EU PV-RMP experience, generic EU submissions experience, EU RMP authoring expertise
Technologies
Global PV-RMP templates, EU pharmacovigilance regulatory frameworks
Responsibilities
Serve as primary author of PV-RMPs using global/regional/local templates; Lead and coordinate cross-functional review and approval processes; Respond to regulatory authority questions and commitments; Independently manage project timelines and submission activities; Represent PV-RM on cross-functional teams; Partner with country affiliates to develop and maintain PV-RMPs; Support implementation of risk minimization measures; Mentor and support training of new team members