Trainee (Replacement of Medicinal Product Dictionary (Art.57) & related international activities)

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 Healthcare Data Office within the Data Analytics and Methods Task Force.

Specific objectives and projects

During your traineeship, you will contribute to the delivery of a strategy for the replacement of the EMA medicinal product dictionary (Article 57 database) with a more modern and efficient tool, improving the data sharing with other systems, such as the reporting of adverse drug reactions (EudraVigilance).

You will be involved in the development and drafting of the strategy including an impact assessment (first project) and in the definition and planning for the subsequent implementing projects that will deliver the strategy (second project). 
In this context, you will be involved in international cooperation activities, contributing with scientific content to the ISO IDMP (Identification of Medicinal Products) standards discussions, including GIDWG (Global IDMP Working Group initiative). You will also have the opportunity to interact with members of the EU regulatory network and international regulators (e.g. FDA). 

More info: 
Article 57 database.

Learning outcomes

In this traineeship, your learning outcomes will be: 

- Gaining a good understanding of the principles to follow for drafting a strategic planning document in the context of data science. 
- Develop networking and communication skills at an international level with multiple stakeholders.
- Understand medicinal product information and the structuring of its information, along with its use in other connected use cases (e.g.: signal detection, PSUR, referrals, pharmacovigilance fee)
- Develop a good understanding of ISO processes for the definition of international data standards. Learn the ISO IDMP standards. 
- Gaining of knowledge and expertise in running of Agile projects

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 or similar  (minimum of three years or more) that must have been obtained within the last 12 months (graduated between 20 May 2023 and 20 May 2024) 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.

Additional skills

In addition to the eligibility criteria, you will have a predisposition for working with structured data (data scientist mindset) and knowledge of Excel.

Behavioural Competencies

You will demonstrate the following behavioural competencies:

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

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2024 – 31 July 2025) 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 €1,858.31 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.