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This position is part of the Risk Management function within the GPS organization, responsible for development and management of Pharmacovigilance Risk Management Plans (PV-RMPs) to support Baxter’s drug and biologic products.
Job Responsibility
Serve as primary author for PV-RMPs, utilizing various regional/local/company templates and ensuring compliance to regional/local regulatory requirements
Facilitate cross-functional review and approval of PV-RMPs
Respond to queries/requests from regulatory authorities regarding PV-RMPs
Independently manage project timelines associated with preparation and submission of PV-RMPs
Represent GPS Risk Management on cross-functional teams
Collaborate with country organizations in developing and managing PV-RMPs and associated commitment activities
Support training of new GPS Risk Management team members
Requirements
Knowledge of worldwide PV-RMP regulations: prior experience with European Union (EU) regulations is required. Prior experience with other regional/local regulations is desired
Prior experience with the implementation of additional risk minimization measures is desired
Excellent analytical and critical thinking skills
Excellent oral, written, and interpersonal skills, including ability and comfort in leading cross-functional group discussions and meetings
Scientific/clinical knowledge and excellent scientific writing skills
Ability to independently manage long- and short-term project timelines and deliverables
Experience in responding to queries/requests from regulatory authorities
Bachelor’s degree in nursing/biologic/medical/clinical field
advanced degree and prior clinical practice experience is desired
Minimum two years’ prior pharmaceutical industry experience in Pharmacovigilance or Medical/Clinical functions
Minimum two to three years’ general experience authoring PV-RMPs. Prior experience authoring EU RMPs is required
experience with generic PV-RMP submissions within the EU is desired. Prior experience authoring PV-RMPs in non-EU regions is desired