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GPS Risk Management Specialist at Baxter International - ApplyBlast

GPS Risk Management Specialist

Baxter International

4 months ago

San Gwann, Malta

Onsite

Full Time

Senior

0 applicants

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About this role

This role involves developing and managing Pharmacovigilance Risk Management Plans (PV-RMPs) for Baxter's drug and biologic products within the Risk Management function. The position requires serving as a primary author, facilitating cross-functional reviews, and responding to regulatory authorities to ensure compliance with regional regulations.

Responsibilities

Serve as primary author for Pharmacovigilance Risk Management Plans
Ensure compliance with regional and local regulatory requirements
Facilitate cross-functional review and approval of risk management plans
Respond to queries from regulatory authorities regarding submissions
Independently manage project timelines for plan preparation and submission

Skills

Qualifications

Bachelor's degree in Nursing, Biology, Medicine, or a Clinical field2+ years of pharmaceutical industry experience in Pharmacovigilance2-3 years of experience authoring Pharmacovigilance Risk Management PlansPrior experience with European Union (EU) regulations requiredAdvanced degree in a clinical field is desired

About Baxter International

baxter.com

Headquarters

Deerfield, Illinois, United States

Company Size

10001+ employees

Founded

1931

View Profile

Baxter International is a global healthcare company that develops and provides medical devices, connected solutions, and advanced injectable technologies for hospitals, physician offices, and home care settings. Their product portfolio spans primary care, hospital care, surgical care, nutritional care, and respiratory health. For nearly a century, Baxter has been committed to saving and sustaining lives by partnering with healthcare professionals and patients to deliver smarter, more personalized care.