Vacancy Qualified Person for Pharmacovigilance (QPPV) – Maastricht


Organization

For a pharmaceutical organisation as well as an independent CRO providing services for human medicinal products and medical devices (CE products), we are currently looking for a Qualified Person for Pharmacovigilance.

The clients of the organisation are mainly small and medium-size pharmaceutical companies worldwide, that often have a pharmacovigilance (PV) system under development or are undergoing major changes with (initial) marketing authorisation applications. To strengthen the PV department, we are looking for an experienced professional to join the organisation as Qualified Person responsible for Pharmacovigilance (QPPV) to ensure complete oversight of the PV systems of the organisation and his business partners.

Function

In main purpose of the role is ensuring 24/7 availability for the safety of medicinal products and medical devices. You will be keeping overview of medicinal product safety profiles and emerging safety concerns. Furthermore, you will be the primary contact for European Medicine Agency (EMA), company affiliates and pharmacovigilance inspections and audits conducted in the EU. You will be responsible for the establishment and maintenance of the PV system of Interdos Pharma BV as well as the PV systems of the other marketing authorisation holders. Other duties and responsibilities include:

  • Ensuring and verifying the information contained in the PSMFs of the marketing authorisation holders is accurate and up to date reflecting the PV systems under the QPPVs responsibility
  • Performing QPPV function within the company and globally, ensuring constant compliance with European PV Legislation and European Regulations
  • Reviewing PSURs, RMPs, (non-)clinical overview and other scientific documents and being aware of risk minimisation measures
  • Building strong working relationships with local Drug Safety Officers in EU Countries
  • Ensuring awareness of compliance with PV requirements. This includes but is not limited to individual case reports and aggregate reports quality and submission timeliness, and implementation of risk minimisation activities
  • Participating in signal management activities and contributing to identification and evaluation of safety signals from all available sources
  • Accountable for continuous pharmacovigilance evaluation of the companies’ medicinal products authorised in the EU
  • Working with safety data exchange agreements (SDEAs) and ensuring timely update of the contracts
  • Awareness of any conditions or obligations adopted as part of marketing authorisations and other commitments relating to safety or safe use of products
  • Ensuring full prompt response to any request from competent authorities in member states and from the Agency for the provision of additional information necessary for the benefit risk evaluation of a medicinal product
  • Being involved in the review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a risk management plan in the EU
  • Having awareness of the validation status of the database

Requirements

Knowledge/experience:

  • Eligible to act as a Qualified Person for Pharmacovigilance under EC/2001/83 Directive
  • Academic (Pharmaceutical) master degree in life sciences
  • Solid knowledge of international pharmacovigilance regulations and guidelines
  • At least 5-10 years of experience in various roles within pharmacovigilance within the pharmaceutical industry, government agency or a PV consultancy organisation
  • Previous experience as EU QPPV (or Deputy) preferred
  • Track record in leading teams
  • Analytical, solution orientated and dynamic approach

Offer

Challenging job in a fast growing and dynamic environment, with a competitive salary and great working conditions. The organisation offers their employees (internal) courses and training for personal development.

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Daniel Donker
Principal Consultant | Biotech & Pharma

+31 6 82 56 44 01
+31 23 754 86 60
d.donker@qtcrecruitment.com