Local Contact for Pharmacovigilance – Estonian & English
iqvia · Tartu
Description du poste
About the role
The Local Contact for Pharmacovigilance will serve as the primary liaison for customers needing pharmacovigilance services for their products. The position can be performed from home, a hybrid setting, or an office anywhere in Europe, offering full flexibility.
Key responsibilities
- Respond promptly to Competent Authority requests, evaluating benefits and risks of medicinal products, including sales, prescription data, and post‑authorization safety studies.
- Stay current with local regulatory changes and ensure risk‑management plans and safety measures are implemented.
- Maintain project budgets and scopes, preparing project files, forms, and templates.
- Provide regular updates to the project manager on metrics, scope changes, and customer concerns, and document issues for the team and management.
- Communicate monthly updates to the EU QPPV/designee and complete required regulatory reports.
- Support overall pharmacovigilance operations as needed.
Required profile
- Bachelor’s degree in life‑science, medicine, pharmacy, nursing or equivalent.
- Minimum 3 years of relevant experience in clinical trial safety or post‑marketing safety, or an equivalent mix of education and experience.
- Fluent written and verbal English (C1) and native‑level Estonian (C2).
- In‑depth knowledge of global, regional and local regulatory requirements, ICH guidelines and SOPs.
- Strong understanding of the pharmacovigilance legal framework in Estonia and the ability to monitor product safety profiles.
- Demonstrated knowledge of compliance and quality management systems.
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iqvia
Tartu
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