Collaborating Expert On Risk Assessment of The Use

5 maanden geleden


Amsterdam Zuid, Nederland European Medicines Agency Voltijd

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

Not applicable TDA Office

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

**Proposed length**: 6 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- MAWP Focus area 2.2. Data analytics, digital tools and digital transformation- Specific projects- Deliverables- Review and drafting of examples and justified proposals for methodology for the assessment of risk of use of AI in regulatory and business procedures utilising data, including identification, categorisation, mitigation and monitoring of risk, including metrics and measures;
- Risk assessments of AI for use in regulatory and business procedures;
- Contribution to discussions to determine the risk of use of AI in identified actual procedures;
- Provide knowledge acquired from the above experiences for input to the development of policy;
- Publication of Risk assessments of AI for use in procedures using regulatory and business data.
- Benefits for the expert- Enhancement and acknowledgment of expertise in the risk assessment of AI in the European Medicines Regulatory Network;
- Gain experience of working in an EU organisation and of the EMA’s work and role in regulatory science.
- Benefits for the collaborating institution- Exchange of knowledge and expertise;
- Joint research undertaking, and if publication, joint publication;
- Building a 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**: MSc in data/information, social sciences (e.g. political sciences, public administration), medicine, health and/or law.
- **Desirable**: MSc including focus on AI.**Experience and additional skills**Desirable**: Proven experience in Risk assessment and management in medicines regulation.**Behavioural competencies**
Essential:
- Communication skills
- Adaptability
- Working with others but also with some degree of autonomy

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands



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