Mgr, Global PV Compliance

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.

This position is a member of Global Patient Safety –Global Pharmacovigilance Compliance and Safety Operations. This role encompasses the management of Compliance to support Quality Management System (QMS), compliance activities and PV inspections/audits worldwide.

Essential Duties and Responsibilities.

The incumbent will perform other duties as assigned.

GPS PV Audit and Inspection readiness

• Responsible and accountable for leading and or support in responding to PV audits/inspections (including North America) and for opening corrective actions/preventive actions (CAPAs) for Safety Operations activities.

PV System Compliance and GPS QMS:

• has oversight responsibility of GPS QMS documents management and training processes, for Safety Operations, PV Technology and Data Management activities, including strategy and compliance, use of BAXU, GPS training assignments and training metric reports.
• has oversight for any agreement withs vendors related to Safety Operations and PV Technology and Data Management activities

Reasonable Accommodation

Vantive 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. Form Link

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