Collaborating Expert On Contribution of Rwe to The

6 dagen geleden

Amsterdam Zuid, Nederland European Medicines Agency Voltijd

**Organizational Unit**: Data Analytics and Methods Task Force

Real World Evidence Office

**Place of work**: Flexible (occasionally on EMA premises and remote).

**Proposed length**: 12 months(extendable if needed).

**Remuneration**: Experts should be salaried by their employer or be a post-graduate student (financed by their educational entity or self-financed).

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines.

The Collaborating Expert Programme is addressed to scientists and professionals who can share their expertise in a particular area of European Medicines Agency’s activities or are interested in collaborative research projects related to EMA’s scientific work.

The aim is to provide a mechanism for EMA and external researchers to collaborate in identifying and tackling important research questions to support regulatory decision-making.

This will help ensure that regulatory science remains at the cutting edge so that EMA can deliver its fundamental mission of protecting human and animal health and facilitating the availability of medicines to patients.

This announcement is governed by the Policy 0080. For further information please visit our Collaborating Expert Programme website.
- Strategic area / objective- This work will support EMA in understanding the use and establishing the value of RWE for EU regulatory decision-making for vaccines. It will also promote transparency by building on EMA’s experience with existing/past submissions, while maximising the knowledge and impact of EMA’s work to support the translation of innovation into vaccines to reach and add value to more EU citizens on the basis of better data and evidence generation.- Specific projects-
- The objectives of this research will be to identify vaccine submissions including RWE; analyse the purpose of use of RWD/RWE (e.g., disease epidemiology/unmet medical need, safety/effectiveness claim, expansion to special populations); analyse its contribution to decision-making in terms of type and suitability of RWD and methodology. Results will be analysed and reported by vaccine product, class of vaccines, and/or disease/pathogen targeted.-
- Deliverables- Protocol outlining the methodology of the research (an initial high-level draft is already available), to be published on the HMA-EMA Catalogue of real-world data studies (europa.eu)
- Manuscript for publication in a peer-reviewed journal
- Benefits for the expert- Gain experience of working with experts from the EMA and better understand EMA’s work and role in regulatory science.
- Contribute to gather vaccine use cases related to RWE submitted in regulatory dossiers, and further understand their scope.
- Support the strategy of EMA to establish use and value of RWE in regulatory decision-making in the specific setting of vaccines.
- Benefits for the collaborating institution- Exchange of knowledge and expertise.
- Joint research undertaking and joint publication
- Building personal and inter-institutional collaboration with EMA.
- Essential requirements**Eligibility criteria**:

- Be an EU or EEA national
- Meet the requirements stated in the profile description;
- Be a paid employee from European academia, research institutions, public sector or international organisations, or a post graduate student within such organisations. Proof of employment/student status and agreement in principle of employer/academic institution will be requested.;
- Have a thorough knowledge of English (at least level C1). Good knowledge of another official EU language (at least B2) is an asset, as per the Common European Framework for Languages.

**University degree(s)**

**Essential**:
- Minimum of a university degree in biomedical sciences, or public health, or regulatory science, or epidemiology/pharmacoepidemiology

**Desirable**:
- Master or PhD degree in pharmacoepidemiology

**Experience and additional skills**

**Essential**:
- Demonstrated experience in writing, analysis and reporting of results in scientific reports and peer-reviewed publications.
- Demonstrated knowledge in the field of RWE generation.
- High-level knowledge of regulatory procedures

**Desirable**:
- Knowledge in the field of vaccinology/vaccine monitoring/vaccine RWE generation

**Behavioural competencies**
Essential:
- Communication skills
- Interpersonal skills
- Working with others
- Adaptability
- Working with others but also with some degree of autonomy

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

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