Senior Manager 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. 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. 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.

Oversee GPS QMS documentation and global PV processes.

Manage the GPS training process.

Supervise GPS global PV agreement processes.

Bachelor's degree or higher in a medical or scientific field, with proven experience in Global Pharmacovigilance compliance within a global-regional-local patient safety framework.

Excellent analytical and problem-solving skills, including CAPA writing and audit report handling.

Effective communication and presentation skills in English, with experience liaising with health authorities and healthcare professionals.