Senior Global PV Compliance Manager & Deputy EU / UK QPPV

Vantive Health LLC; Madrid; A distancia; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

Vantive Health LLC is seeking a Senior Global PV Compliance Manager to oversee pharmacovigilance compliance and quality management within an international team. This role involves acting as the contact for EU/UK authorities, leading audits, and managing training processes to enhance patient safety. The ideal candidate has extensive experience in pharmacovigilance, strong leadership skills, and a bachelor's degree in a relevant field, contributing to a mission focused on improving lives through innovative therapies.

Formación

• Experience in global pharmacovigilance compliance.
• Experience in CAPA writing and audit report management.
• Experience as deputy EU and UK QPPV is a plus.

Responsabilidades

• Act as the contact person for Competent Authorities on medical safety requests.
• Oversee safety profiles and monitor emerging safety concerns.
• Lead preparation and conduct of PV audits and inspections.

Conocimientos

Leadership

Analytical skills

Interpersonal skills

Problem-solving

Communication

Educación

Bachelor’s degree in a medical or scientific field

Descripción del empleo

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

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 key part of this role involves leading and facilitating GVP audit and inspection activities, as well as supporting management of GPS global PV agreements.

Additionally, you will 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 are open to applicants from all EU countries.

What you’ll be doing

• Act as the contact person for the Competent Authorities for medical safety requests / questions regarding medicinal products licensed in the EU / UK, in the absence of the QPPV. Serve as a single contact point for 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 doctors for emergency assessments, case evaluations, safety signal management, and benefit-risk assessments. Review and support PV content in drug labeling.
• Lead preparation and conduct of PV audits and inspections, ensuring stakeholder training and inspection readiness.
• Manage and facilitate audits and inspections, including CAPA handling for audit observations.
• Oversee GPS QMS documentation and GPS pharmacovigilance processes.
• Manage the GPS training process.
• Supervise GPS global PV agreement processes.

What you’ll bring

• Bachelor’s degree in a medical or scientific field, with proven experience in global pharmacovigilance compliance, working within a global-regional-local patient safety model.
• Excellent leadership and interpersonal skills, demonstrated through successful PV audits and inspections, including regulatory authority inspections (EMA, MHRA, FDA, Chinese HA, PMDA, TGA).
• People management experience, with the ability to motivate and develop multicultural teams.
• Strong analytical and problem-solving skills, with experience in CAPA writing and audit report management.
• Excellent communication and presentation skills in English, with the ability to effectively communicate with health authorities and healthcare professionals.
• Experience as deputy EU and UK QPPV is a plus.

Reasonable Accommodation

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

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