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.
Essential Duties and Responsibilities
Serve as primary author for PV-RMPs, utilizing various regional/local/company templates and ensuring all PV-RMPs are prepared according 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.
Assist RM manager/commitment tracking tool owner with planning and oversight of PV-RMP commitments.
Knowledge of worldwide PV-RMP regulations: prior experience with European Union (EU) regulations is required. Experience with other regional/local regulations is desired.
Excellent analytical and critical thinking skills.
Excellent oral, written, and interpersonal communication skills, including ability to lead 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.
Exposure to working relationship with 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.