Position at EMA - Seconded National Expert in Epidemiology

The European Medicines Agency (EMA) is looking for a Seconded National Expert/Epidemiology specialist in the Data Analytics and Methods Task Force, to support ongoing work on RWE generation to support regulatory decision-making.

This position is open for staff from European public-sector bodies who can work at the EMA for short periods of time through the national expert on secondment (SNE) programme. The aim of this programme is to enhance and develop the relationship between European public administrations.

Role description

• Provide expertise for the identification, validation and utilisation of electronic healthcare data/claims data sources, patient registries and innovative data sources in Europe to support the EMA regulatory science strategy and the regulatory decision-making;
• Use and develop appropriate knowledge in the selection of fit-for-purpose real-world data to study populations, diseases and the performance of medicines (including vaccines) once placed on the market;
• Based on good (pharmaco-)epidemiology principles, design, conduct and coordinate non-interventional studies on the safety and effectiveness of medicinal products (with development of study protocol, statistical analyses and report writing) using in-house electronic health care databases or other pathways of RWE generation, including (but not limited to) drug utilisation studies, studies on the effectiveness of risk minimisation measures and etiological studies
• Support EMA scientific committees and working parties in methodological aspects that contribute to scientifically sound and efficient drug development as well as informed decision-making process;
• Contribute to the development of scientific guidelines on the design and analysis of non-interventional studies;
• Develop training materials for the EU Regulatory Network on assigned subjects;
• Advise companies developing medicines on the design of non-interventional studies;
• Contribute to the yearly goal of the workstream as part of the team.

Deadline for applications: 1 July 2024

Further information and application on the EMA website: SNE/Epidemiology Specialist Job Details | EMA (europa.eu)