GPS Risk Management Specialist

Responsibilities

• Serve as the primary author for Pharmacovigilance Risk Management Plans (PV-RMPs) using various regional, local, and company templates.
• Ensure all PV-RMPs comply with regional and local regulatory requirements.
• Facilitate cross-functional reviews and approvals for all risk management documentation.
• Respond to queries and requests from regulatory authorities regarding PV-RMPs.
• Independently manage project timelines associated with the preparation and submission of plans.
• Represent the GPS Risk Management function on cross-functional teams.
• Collaborate with country organizations to develop and manage PV-RMPs and associated commitment activities.
• Support the training of new members within the GPS Risk Management team.

Requirements

• Bachelor’s degree in nursing, biologic, medical, or a clinical field.
• Minimum of 2 years of pharmaceutical industry experience in Pharmacovigilance or Medical/Clinical functions.
• 2 to 3 years of experience specifically authoring PV-RMPs, including required experience with EU RMPs.
• Strong knowledge of worldwide PV-RMP regulations, specifically European Union (EU) regulations.
• Excellent scientific writing and clinical knowledge.
• Strong analytical, critical thinking, and interpersonal skills.
• Ability to lead cross-functional group discussions and manage complex project timelines.

Preferred Qualifications

• Advanced degree and prior clinical practice experience.
• Experience with the implementation of additional risk minimization measures.
• Experience with generic PV-RMP submissions within the EU.
• Experience authoring PV-RMPs in non-EU regions.

About the Company

Baxter is a global healthcare leader dedicated to saving and sustaining lives. Since 1931, we have been at the forefront of innovation, bringing smarter, more personalized care to patients around the world. We strive to redefine healthcare delivery through a culture of courage, trust, and collaboration.