Local Contact for Pharmacovigilance

Local Contact for Pharmacovigilance, you will act as local contact for pharmacovigilance for customers requiring the services for their product(s). This role can be conducted either Home Based / Hybrid / Office based from anywhere in Europe - the choice is yours. RESPONSIBILITIES • 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. • 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. • Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns; communicate and document project issues to project team members and department management in a timely manner; • Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required. • Support pharmacovigilance operations as required. MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent. · 3 years of prior relevant experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience. · Excellent written and verbal skills in English (min. C1) and Estonian language (min. C2 / native). • In-depth knowledge of applicable global, regional and local regulatory requirements, International Conference on Harmonization (ICH) guidelines, and relevant Standard Operating Procedures (SOPs). • Very good knowledge of the pharmacovigilance legal framework in Estonia. • Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product. • Demonstrate an understanding of compliance and of quality management systems. #LI-Remote #LI-Hybrid #LI-Onsite IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.