Local Contact for Pharmacovigilance with Estonian and English language

Job description

Local Contact for Pharmacovigilance with Estonian and English language As the 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.

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