Sr Executive Post Market Surveillance

4 weeks 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.

Job Responsibilities:

Effectively manage and process complaints, which includes performing daily tasks associate with processing complaint records across multiple product lines, which may include:Opening complaint records.Collecting necessary complaint information.Performing follow-up with the customer (written and verbal).Determining reportability of complaints.Creating associate Regulatory reports (e.g., MDRs) per regulations.Evaluating complaints for need to investigate and coordinating sample retrieval.Responding to customer complaints (written and verbal).Timely closure of complaints, as per procedure. Effectively manage workflow, identifying and escalating issues. Participate in continuous improvement efforts and projects, as assigned. 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. Knowledge of assessing clinical knowledge (literature articles, clinical data etc.)

Qualifications/Requirements:

Minimum of an Associate’s Degree required in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN) Minimum of 3 years of experience in Medical Device Industry Preference would be given to candidate having knowledge of writing clinical documents (PSUR/CER) Fluent in English: solid written and verbal communication skills. Ability to prioritize and multitask. Good Knowledge of Word, Excel and PowerPoint Ability to work with cross-functional teams to interact effectively with peers, management and customers. Readily accepting of assignments to new/different products. Strong critical thinking and problem-solving skills. Ability to work independently. Detail oriented. Customer focused.

  • 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...


  • 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...


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    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...


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    **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...


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    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...


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    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...


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    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...


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