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