Sr.Executive, Product Surveillance

3 months ago

Gurugram, India Baxter Full time

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Gather complaint information from reporter (examples: performing due diligence, facilitating sample retrieval, etc);
Ensure consistency of complaint records & proper documentation (Good Documentation Practices);
Assess complaint information to determine regulatory reportability as per procedures & regulations; 
Work with plant quality organizations, technical services and/or suppliers to coordinate complaint investigations;
Maintain compliance to regulations and procedures;
Work on Post Market Surveillance requirements as part of the EU Medical Device Regulations, including but not limited to:
- Post Market Surveillance Plans;
- Post Market Surveillance Reports;
- Periodic Safety Update Reports (PSURs);
- Clinical Evaluation Reports (CERs)
Ensure any emerging trends from the field or other PMS data are highlighted and reported to relevant management in real time.

Ensure accurate and detailed documentation of complaint information.
Stay informed about applicable regulations and guidelines related to vigilance reporting.
Initiate and complete vigilance reports within regulatory timelines.
Maintain a comprehensive database of vigilance reports for internal tracking.
Provide training to team members on new processes and updates.

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