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

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

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Senior Global PV Compliance Manager & Deputy EU/UK QPPV, Lisboa

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Client:

Vantive, Unipessoal Lda Prt

Location:

Lisboa, Portugal

Job Category:

Other

-$0-0/monthly

EU work permit required:

Yes

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Job Views:

2

Posted:

28. 08. 2025

Expiry Date:

12. 10. 2025

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Job Description:

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.

AsSenior
Global
PVCompliance
Manager & Deputy EU/UK QPPV, you will be responsible forglobal
PVCompliance, 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 Gv
P audit and inspection activities, as well as supportingmanagementof GPSglobal
PV agreements.

Moreover, you will be serving as the Deputy Qualified Person for
Pharmacovigilancefor 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
PVCompliance, within the wider
Global
Patient
Safetyteam, you will be managing a close team of experts based in the EU and US. Occasional international travel on an
- 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 medicalsafetyrequests/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.
• Overviewssafetyprofiles, knowledge of any emergingsafetyconcerns and any other information relating to evaluation of the
  - 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, safetysignal proportionality or
  - risk assessments. Review and support PV
  - risk content sections of drug therapeutic product labeling.
• Lead preparation and conduct of PV audits and inspections, ensuring that all stakeholders are properly trained incomplianceand 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 propermanagementof GPS QMS documents and has oversight responsibility for GPSPharmacovigilanceglobalprocesses.
• Manages the GPS training process.
• Supervises and manages the GPSglobal
  PV agreement process

What you’ll bring

• Bachelor´s degree minimum in a medical or scientific field, with proven experience in
  Global
  Pharmacovigilance, specificallycompliance, working in
  -
  - local patientsafetymodel where
  - way direct communication has been required to ensure functional alignmentglobally.
• 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 peoplemanagementexperience as well as ability to motivate, lead and develop a multicultural team
• Outstanding analytical and
  - 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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