Senior Global PV Compliance Manager & Deputy EU/UK QPPV Oeiras

Senior Global PV Compliance Manager & Deputy EU/UK QPPV
Oeiras
Oeiras, Distrito de Lisboa, Portugal

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, but 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 mediocrity. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Position: Senior Global PV Compliance Manager & Deputy EU/UK QPPV

In this role, you will be responsible for global PV compliance, supporting the development and maintenance of GPS Quality Management System, and overseeing GPS training strategy. A key aspect of this position involves leading and facilitating Gv
P audit and inspection activities, as well as supporting the management of GPS global PV agreements.

You will also serve as the Deputy Qualified Person for Pharmacovigilance (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 welcome applicants from all EU countries.

Key Responsibilities

• Act as the contact for Competent Authorities regarding safety requests/questions for medicinal products licensed in the EU/UK, in the absence of the QPPV, and serve as a 24-hour contact point with the QPPV.
• Oversee safety profiles, monitor emerging safety concerns, and evaluate
  - benefit profiles of medicinal products authorized in the EU/UK.
• Coordinate with medical doctors for emergency assessments, case evaluations, safety signals, and
  - risk assessments. Review and support PV content in drug labeling.
• Lead the preparation and conduct of PV audits and inspections, ensuring stakeholder training and inspection readiness.
• Manage and facilitate audits and inspections, including CAPA handling of audit observations.
• Oversee GPS QMS documents and GPS pharmacovigilance processes.
• Manage the GPS training program.
• Supervise GPS global PV agreements.

Qualifications

• Bachelor’s degree in a medical or scientific field, with proven experience in Global Pharmacovigilance compliance within a
  -
  - local patient safety model.
• Strong leadership and interpersonal skills, with experience leading PV audits and regulatory inspections (EMA, MHRA, FDA, etc. ).
• Experience managing multicultural teams and motivating staff.
• Excellent analytical and
  - solving skills, especially in CAPA writing and audit report management.
• Effective communication and presentation skills in English, with experience interacting with health authorities and healthcare professionals.
• Experience as deputy EU and UK QPPV is a plus.

Additional Information

Reasonable Accommodation

Vantive is committed to providing reasonable accommodations for individuals with disabilities. If needed, please click Form Link to request accommodations during the application or interview process.

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Location: Quinta da Fonte, Edificio D. Pedro I, Rua dos Malhões, 2770-071 Lisbon, Portugal