Medical Safety Writer

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining liveswhere your purpose accelerates our mission.

The Medical Safety Writer (MSW) is responsible for the preparation and completion of aggregate safety reports for submission to regulatory agencies worldwide.

• Write and prepare standalone post-marketing aggregate safety reports, such as Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs) and associated reports, for regulatory submission perform quality control reviews of aggregate safety reports
• Ensure all assigned aggregate safety reports are processed and submitted according to regulatory requirements and internal timelines
• Assist in the preparation of timely function-specific responses to regulatory authority requests and of function-specific responses to assessment reports from regulatory authorities
• Collaborate with Drug Safety Physicians, EU-QPPV, and GPS Risk Management Head/Specialist concerning safety issues relative to safety writing activities
• Interface with other Baxter functional groups, such as Regulatory Affairs, Clinical/Medical Affairs, Quality, Data Management, or other business units as needed
• Support the creation, improvement and maintenance of Medical Safety Writing standardized departmental procedures and processes
• Participate on assigned project teams and committees

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.

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