Senior Global PV Compliance Manager & Deputy EU/UK QPPV (m/f/d)

Vantive; Deutschland; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A leading organ therapy company is seeking a Senior Global PV Compliance Manager to oversee pharmacovigilance compliance efforts and support global quality management systems. The role involves significant leadership responsibility and interaction with regulatory authorities, requiring strong analytical skills and people management experience. Located in Germany but open to applicants from all EU countries, the position offers an opportunity to make a significant impact on patient safety.

Qualifikationen

• Proven experience in Global Pharmacovigilance compliance.
• People management experience leading multicultural teams.
• Experience maintaining safety profiles and CAPA writing.

Aufgaben

• Responsible for global PV compliance and GPS Quality Management System.
• Lead preparations and conduct PV audits and inspections.
• Acts as the contact for Competent Authorities.

Kenntnisse

Leadership

Analytical Thinking

Problem Solving

Communication

Ausbildung

Bachelor's degree in a medical or scientific field

Jobbeschreibung

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.

Your future role at Vantive

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 be serving 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 be managing a close team of experts based in the EU and US. Occasional international travel on an ad-hoc basis is to be expected.

We are open to applicants from all EU countries.

What you'll be doing

• Acts 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 acts as a single contact point for the Competent Authorities on a 24-hour basis
• Overviews safety profiles, knowledge of any emerging safety concerns and any other information relating to evaluation of the risk-benefits of the medicinal products for which Vantive holds authorizations in the EU/UK
• Maintaining access to a medical doctor for the assessment of medical emergencies, case evaluations, safety signal proportionality or benefit-risk assessments. Review and support PV benefit-risk content sections of drug therapeutic product labeling
• Lead preparation and conduct of PV audits and inspections, ensuring that all stakeholders are properly trained in compliance and inspection readiness needs
• Responsible for managing and facilitating audits and inspections, providing adequate CAPA handling of the observations available in audit reports
• Accountable for the proper management of GPS QMS documents and has oversight responsibility for GPS Pharmacovigilance global processes
• Manages the GPS training process
• Supervises and manages the GPS global PV agreement process

What you'll bring

• Bachelor's degree minimum in a medical or scientific field, with proven experience in Global Pharmacovigilance, specifically compliance, working in a global-regional-local patient safety model where two-way direct communication has been required to ensure functional alignment globally
• Excellent leadership and interpersonal skills demonstrated through successfully leading and driving PV audits and inspection processes, in particular Regulatory Authority Inspections (i.e EMA, MHRA, FDA, Chinese HA, PMDA and TGA)
• Successfully demonstrated people management experience as well as ability to motivate, lead and develop a multicultural team
• Outstanding analytical and problem-solving skills proven through experience with CAPA writing and handling of the audit report observations
• Strong communication and presentation skills in English leading to effective communication with Health Authorities and Health Care Professionals
• Prior experience as deputy EU and UK QPPV is a plus

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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