Senior Global PV Compliance Manager & Deputy EU / UK QPPV

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.

Role Overview

As Senior Global PV Compliance Manager & Deputy EU / UK QPPV , you will be responsible for global PV Compliance, supporting the development and maintenance of GPS Quality Management System, with oversight of GPS training strategy. A crucial part of the position will be leading and facilitating GvP audit and inspection activities, as well as supporting management of GPS global PV agreements.

Moreover, you will serve as the Deputy Qualified Person for Pharmacovigilance for the European Union (EU QPPV) and UK QPPV, working closely with the EU / UK QPPV.

Reporting to the EU / UK QPPV and Head of Benefit Risk & Global PV Compliance, within the wider Global Patient Safety team, you will manage a team of experts based in the EU and US. Occasional international travel may be required.

We are open to applicants from all EU countries.

Key Responsibilities

• Act as the contact person for the Competent Authorities for medical safety requests / questions regarding a medicinal product licensed in the EU / UK in the absence of the QPPV. Together with QPPV, act as a single contact point for the Competent Authorities on a 24-hour basis.
• Oversee safety profiles, monitor emerging safety concerns, and evaluate risk-benefit profiles of medicinal products authorized in the EU / UK.
• Maintain access to medical professionals for emergency assessments, case evaluations, safety signal analysis, and benefit-risk assessments. Review and support PV content in drug labeling.
• Lead the preparation and conduct of PV audits and inspections, ensuring stakeholder training in compliance and inspection readiness.
• Manage and facilitate audits and inspections, addressing CAPA and audit observations.
• Oversee GPS QMS documentation and global PV processes.
• Manage the GPS training process.
• Supervise GPS global PV agreement processes.

Qualifications

Additional Information

Vantive is committed to providing reasonable accommodations for individuals with disabilities. If needed, please follow the provided link to request support during the application or interview process.

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