Spec, RA
Req # JR - 133134 Location Ahmedabad, Gujarat, India Job Category Regulatory Affairs Date posted 04/19/2024This 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 lives—where your purpose accelerates our mission.
Aggregate PSUR related activity
PSUR and ACO scheduling and submission
Review and preparation of PADER/PSUR/PBRER, coordination for their submission as per their applicable dates
Handling of request received from central and local regulatory affairs and PV department with respect of timeline.
Conduct safety review
Conducting risk benefit analysis
RMP Related activities
Assist in developing RMP and allied activities
Coordinate with Global team as well as in-house reg team to ensure RMPs are submitted as per their applicable dates
Signal management
Conduct or assist in all signal detection activities as assigned
Preparation and the maintenance of EURD database and coordination with global team
Ensure the maintenance of XEVMPD database and coordination with global team
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 link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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Address
Tower A Ground Floor
Tower B 21st and 22nd Floor
Gujarat- 380058
Gujarat
India Explore this location
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