Trainee (Development of medicines for children and paediatric pharmacovigilance)

The European Medicines Agency (EMA) is a decentralised agency of the European Union, located in Amsterdam. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

This traineeship opportunity is open for applications until 30 September 2026 23:59 CEST, with an intake on 1 March 2027.

Traineeship in development of medicines for children and paediatric pharmacovigilance

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 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.

We are looking for a trainee in the Paediatric Medicines Office.

Context

Medicines used in children require continuous safety monitoring, both during development and after they are authorised for use. The European Medicines Agency plays an important role in ensuring that medicines remain safe and effective for paediatric patients by reviewing safety information and supporting regulatory actions when needed. Medicine developers working on new treatments must submit Paediatric Investigation Plans (PIPs), which describe how a medicine will be studied and developed for children. Safety aspects are an important element in the assessment of these plans.

Project and tasks

As a trainee, you will work in an engaged team within the Paediatric Medicines Office, collaborating closely with colleagues from pharmacovigilance (medicine safety monitoring) and non-clinical scientific areas. You will contribute to a project focused on reviewing and strengthening the safety monitoring of medicines used in children. The work will examine how ongoing safety procedures are managed for paediatric products and how safety measures have evolved over time.

Key tasks will include:

• Reviewing a selection of ongoing safety monitoring procedures involving medicines used in children
• Comparing historical and current safety measures implemented for these medicines
• Identifying trends, gaps, and opportunities to further strengthen paediatric safety monitoring activities
• Contributing to findings that will support the assessment of submitted Paediatric Investigation Plans (PIPs)
• Summarising findings to support internal discussions and future improvements, with the aim of contributing to a scientific publication in a peer-reviewed journal

Learning outcomes

Are you a recent graduate or early-career professional interested in public health, regulatory science, and the development of medicines for children? This traineeship offers a unique opportunity to gain hands-on experience within the European regulatory system for paediatric medicines.

During the traineeship, you will:

• Explore the EU regulatory framework for pharmacovigilance and paediatric medicines, including the Paediatric Regulation and key scientific guidance
• Gain insight into the full lifecycle of medicines developed for children, and understand how safety monitoring and risk management evolve over time
• Learn how the European Medicines Agency (EMA) evaluates paediatric development programmes through the assessment of Paediatric Investigation Plans (PIPs), including getting hands-on assessment experience
• Build practical skills in analysing regulatory and scientific safety data, identifying trends, and contributing to evidence-based discussions that support decision-making
• Work in an interdisciplinary and international environment, collaborating with experts across regulatory-scientific fields in a very motivated and supportive team
• Engage with paediatric medicine development across all age groups, including neonates, from early-stage safety and scientific considerations to paediatric investigation plan development with clinical trials and ongoing safety monitoring
• Gain experience in drafting a scientific regulatory paper for publication

Why apply?

These learning outcomes will provide a strong foundation for graduates interested in regulatory science, paediatric drug development, and ensuring safe and effective medicines for children across Europe.

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 relevant university degree (minimum of three years or more) in medicine, pharmacy or life sciences, that must have been obtained between 30 September 2025 and 30 September 2026, 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. Have a thorough knowledge of English (at least level C1) and good knowledge of another 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.

Additional skills

• Familiarity with the pharmacovigilance and paediatric regulatory frameworks in the EU
• Excellent English in speaking and writing
• Analytical skills

Behavioural competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills
• Working with others
• Adaptability
• Research and analytical skills
• Learning and development

Conditions of traineeship

The traineeship is offered for 10 months (1 March 2027 – 31 December 2027) 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 €2,049.77 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.

What we offer

• Meaningful work contributing to protecting the health of every individual and animal in Europe within a multinational, multidisciplinary team
• Development opportunities such as mentoring, peer coaching and career reflection programmes
• Work-life balance through flexible working arrangements, teleworking, generous annual leave and official holidays