European Qualified Person for Pharmacovigilance (QPPV)
- Experience Level
- Experienced (non-manager)
IQVIA is seeking a European Qualified Person for Pharmacovigilance (QPPV). This individual will report to the Senior Director Pharmacovigilance, Oversight and Analytics and will have broad compliance and execution responsibilities and system applicable in the European Union. Can be based from any EU country
Establishing, maintains and is legally responsible for the Marketing Authorization Holder’s pharmacovigilance system in the EU .
Establishing and maintaining/managing the Marketing Authorization Holder’s pharmacovigilance system in compliance with EMA GVP modules.
Having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the Marketing Authorization Holder holds authorizations
Respond fully and promptly to requests from Regulatory Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal products.
Remaining up to date and aware of any changes in EU regulatory requirements
Ensuring the necessary mechanisms and regulatory measures adopted for safety reasons and as part of risk management plans are carried out across the EU
Ensuring that the conduct of pharmacovigilance and submission of all pharmacovigilance related documents are in accordance with the legal requirements and GVP modules.
Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data submitted to the competent authorities in Member States and the Agency.
Providing any other information relevant to the benefit risk evaluation to the competent authorities in Member States and the Agency.
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).
Acting as a contact point for pharmacovigilance inspections
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Have documented experience in the following areas:
Case reporting or case medical review
PSUR generation/submission or medical review
Safety / signal review meetings
PV Project Management / PV Project Medical Advisor
Communication with regulatory authorities
Sound appreciation of post-marketing SOPs
Have completed training specific to post-marketing PV
Verify continuous self-improvement / training and be ‘up-to-speed’ with changing pharmacovigilance regulations and requirements
Demonstrate an understanding of the legal framework for pharmacovigilance in the EU and have knowledge of applicable ICH and CIOMS guidelines
Demonstrate capability to deal directly with regulatory authorities and undergo questioning by regulatory authority inspectors during statutory inspections
Appreciate how to maintain an overview of the safety profile of the product
Understand what may change the benefit/risk balance of a product
Possess an understanding of compliance and of quality management systems
Be willing to provide support to and maintain a robust overview of the activities of local QPs/ responsible persons both within and outside the EU
Be able to rapidly gain access to up-to-date product safety data at short notice 24/7 (this safety data must be available at one point in the EU)Be available to attend the monthly IQVIA QPPV meetings in person or by phone
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Possess a degree in medicine, pharmacy or a life science, and at least two years’ experience in post marketing pharmacovigilance. Must reside in an EU member state
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.