SNE/Epidemiology Specialist

About this position

Support regulatory decision-making process by interacting with the different EMA committees and other stakeholders to stimulate research topics requests and by conducting non-interventional (observational) studies with the most appropriate design and methodology to generate and deliver robust and reliable real-world evidence to the EMA, its committees, the regulatory network and other stakeholders.

In this role you will

• Engage with the different stakeholders, and especially the EMA committees’ members, to understand the needs and stimulate the demand in terms of research questions that could be addressed by the generation of Real-World Evidence (RWE);
• Use and develop appropriate knowledge in the selection of fit-for-purpose real-world data (RWD) to study populations, diseases and the performance of medicines (including vaccines) once placed on the market, to support regulatory decision making;
• Based on good (pharmaco-)epidemiology principles, design, conduct and coordinate non-interventional studies (NIS), including (but not limited to) drug utilisation studies, studies on the effectiveness of risk minimisation measures, studies on the safety and effectiveness of medicinal products, and etiological studies;
• Support EMA scientific committees and working parties in methodological aspects (related to RWD/ RWE) 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 observational research;
• Develop training materials for the EU Regulatory Network on assigned topics;
• Contribute to the yearly goal of the workstream as part of the team.

Apply if you meet these eligibility criteria

• Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway; 
• Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union;
• Are currently employed in the public sector (such as a public intergovernmental organisation (IGO) national / regional / local public administration) in a European Union (EU) Member State and are due to remain in such employment for the foreseen duration of the SNE position.

Communication and professional contacts

Required to regularly communicate (verbally and in writing) information, which requires careful explanation and interpretation, taking into account what to communicate and how best to convey the information and messages. Writing and creating information that is specialist, sensitive, confidential, legal and/or regulatory in nature.

Regular professional contacts with others inside and/or outside the Agency on functional matters. Solicits/gives information, provides advice/guidance and creates use initiative. A likely requirement is to influence others’ thinking and negotiate with various parties within own job responsibilities. Normally connected to the Agency's core business or a project.

Essential requirements

Education

• A level of education which corresponds to completed university studies of at least three years attested by a diploma;

Field of study

• Biomedical sciences, or public health, or regulatory science, or epidemiology/pharmacoepidemiology or related scientific filed;

Experience

3 years from the time when a university degree was awarded on completion of a minimum of three years of study;

Proven experience in at least one of the following:

• working in a regulatory environment related to the evaluation of medicines or interacting with regulatory agencies (eg., assessing/ giving advice on dossiers (with RWE) in a regulatory context (either in pre- or post-approval settings));
• designing (eg., with use of innovative designs such as self-controlled designs and designs mixing clinical trial data with real-world data) and conducting non-interventional studies, including operational work in protocol development and data analysis, interpretation and reporting;
• developing and delivering training on designs and methodologies for observational data and studies;
• engaging and communicating with various stakeholders on the needs, use and value of RWD and RWE in the regulatory context.

Skills and knowledge
Excellent in (scientific) communication; used to engage with various stakeholders and work in a multidisciplinary team and in a multicultural environment.

Nice to have

Education

• Completed PhD or master’s degree in (pharmaco-)epidemiology or biostatistics applied to RWD, medicine, pharmacy, regulatory science, mathematics, data science, computer science or related scientific subjects.

Experience

• In coordinating research projects; in centralised regulatory procedures.