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Specialist, RA at Baxter International - ApplyBlast

Specialist, RA

Baxter International

4 months ago

Ahmedabad, Gujarat

Hybrid

Full Time

Senior

0 applicants

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About this role

This role involves managing aggregate safety reports like PSUR/PBRER/PADER for Baxter's Pharma segment, including review, coordination, and submission scheduling. The position also covers Risk Management Plan (RMP) and Content Overview (CO/NCO) activities, signal management, and maintaining the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD). Responsibilities include generating risk evaluation reports (RSI/CCDS) and monitoring fluxguard labels globally.

Responsibilities

Coordinate PSUR/PBRER/PADER study authoring and submissions
Manage global risk management plan development and timelines
Generate and maintain Case Causal Status and Risk Updates
Monitor Extended EudraVigilance Medicinal Product Dictionary
Execute fluxguard label monitoring across global markets

Skills

Qualifications

Life Sciences DegreePharmacovigilance Certification

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.