VP/Executive Director, EU QPPV (gn)

Our client is an international pharma company with a recently acquired oncology division, looking for an EU-QPPV on VP or Executive Director level to start as the first Oncology PV hire in Europe.

 

Client

  • Global Pharma
  • New Oncology division
  • Exciting pipeline with recent and upcoming filings

 

Your advantages:

  • Flexibility in every sense; from remote work to defining and building the PV functions and systems
  • Attractive salary package
  • Work from anywhere in EU

 

Position:

  • Awareness of risk minimisation measures
  • Awareness and oversight of the content of risk management plans
  • Review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU
  • Ensuring conduct of pharmacovigilance and submission of all PV-related documents in accordance with the legal requirements and GVP;
  • Ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency
  • ensuring a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product
  • Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals)
  • Overseeing safety and benefit-risk profiles for the Oncology portfolio and any emerging safety concerns
  • Ensure preparedness for safety audits
  • Ensuring and verifying that the information contained in the Pharmacovigilance System Master File (PSMF) is an accurate and an up-to-date reflection of the PV system
  • Acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections and audits

Für nähere Informationen kontaktieren Sie bitte: / For more information please contact:

Christian Rommerskirchen
+49 0)89 212 65 333
rommerskirchen@conqure.de

Kontakt!