Trainee (Optimising feasibility assessment for RWD studies)

About the traineeship programme

The Agency is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme or PhD students or Master's students (who posses a previous degree), who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly in the interest of the trainee’s training and principally serve to increase the trainee’s knowledge and to gain relevant experience.

Placement description

We are looking for a trainee in the Data Analytics and Methods Task Force.

Specific objectives and projects

Over the past few years, the network has been processing an increasing amount of data to monitor medicines (but not only) by generating real-world evidence (RWE) and contributing to EU-wide health policies. As part of its strategy, the network also aims to maximise the use of data and evidence generation to support decision making. One example of this approach is the intention to embed the routine use of EU healthcare data into the network’s processes, including data from the Data Analysis and Real World Interrogation Network (DARWIN EU).

Since few years, DARWIN EU as well as other pathways (e.g., framework contracts) are used to generate robust and reliable evidence based on real-world data. More than 100 study questions have been addressed up to now, and the initial step is to go through a feasibility assessment before initiation of a formal study.

With this experience, the trainee will:

1) be involved in identifying the studies (DARWIN EU and framework contract studies) that will be in scope of the project (based on clear inclusion and exclusion criteria),

2) contribute to a systematic review of feasibility assessments to characterise feasibility assessments and their objectives, according to disease area, study type, timelines, number of review rounds and recommendations,

3) describe the type of information received for each feasibility assessment and objective,

4) help to describe how feasibility assessment recommendations informed decisions around study objectives, study design, and whether the study was initiated,

5) correlate feasibility assessment characteristics with the outcome of completed non-interventional studies in relation to protocol changes or study limitations that emerged, and

6) finally provide recommendations on the key considerations when conducting feasibility assessment to inform process and document templates, as the ultimate aim will be to know if some adaptations in the process would be needed and how this could be improved.

Learning outcomes

During this traineeship you will gain knowledge in the following areas:

• Understand the role of feasibility assessment for the conduct of RWD studies to support regulatory decision making
• Assess strengths and limitations of the current process in place via a selection of studies from DARWIN EU and framework contracts
• Assess what is the value and the possible impact of the studies done to support the EMA activities
• Gain knowledge of the Agency’s processes and procedures in the generation of real-world evidence for regulatory decision making

Eligibility criteria

To be eligible for consideration for this placement, you are required to:

1. enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
2. possess a university degree in Pharmacy, medicine, biology, biostatistic or, pharmacoepidemiology (minimum of three years or more) that must have been obtained between 6 May 2024 and 6 May 2025 or be a university student on an Erasmus + or a similar programme or a PhD student or a Master's student with a previous fully finished degree in the areas mentioned before.
3. a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2) of the Common European Framework for Languages

For criteria 1 and 2, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the procedure.

Behavioural Competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills – cross-cultural sensitivity
• Working with others – team collaboration
• Adaptability – adaptability & agility
• Research and analytical skills – analysing and problem-solving

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2025 – 31 July 2026) and takes place at the Agency’s premises in Amsterdam with possibility for teleworking up to 40% of working time from The Netherlands and occasional teleworking from outside The Netherlands. Traineeships are offered for either full-time or part-time (80% or 50%) if combined with university studies.

The Agency pays a monthly stipend of €1,942.19 for a full-time traineeship (reduced accordingly for 80% or 50%) and a travel contribution upon joining the Agency.

Each trainee will have a mentor at the Agency who will guide the trainee through the programme.

The conditions of employment are stated in the Executive Decision on rules governing the traineeship programme at the EMA available here.