Local Contact for Pharmacovigilance with Estonian and English language
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.
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