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Sr Executive, Product Surveillance
2 weeks ago
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
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 is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
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.
Reasonable Accommodation
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