Description
As 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.