UK National Contact for Pharmacovigilance

· Act as the local Qualified Person in accordance with requirements set out in IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).

· Availability on a 24/7 basis to receive calls from the local Competent Authority as required.

· Act as the contact point for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors during statutory inspections.

· Respond fully and promptly to requests from Competent 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.

· Verifies that his/her name and contact details have been notified to the Competent Authority upon contract commencement.

· Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.

· Establish and maintain a thorough understanding of each project's budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.

· Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns.

· Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports.

· Informing relevant competent authorities in Member States immediately of any important

safety concern which has been identified in the course of a study.

· Other post marketing pharmacovigilance responsibilities when required.

· 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.

· Resident in the United Kingdom with fluent English language skills (at least C2).

· Excellent command of the English language.

· Knowledge of applicable global, regional and local regulatory requirements, International Conference on Harmonization (ICH) guidelines, and the pharmacovigilance legal framework in the United Kingdom.

· Ability to maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product.

· Understanding of compliance and of quality management systems.

· Availability by phone 24/7 for Competent Authority enquiries.

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IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.