The European Medicines Agency (EMA) defines real-world data (RWD) as routinely collected data relating to patient health status or the delivery of health care from a variety of sources other than clinical trials, and real-world evidence (RWE) as information derived from the analysis of RWD, this information being valid, reliable and appropriate for regulatory decision-making on medicinal products. RWE-related activities impact across the EMA and the European Medicines Regulatory Network (EMRN). They are led and coordinated in the Real World Evidence workstream of the Data Analytics and Methods Task Force. This workstream provides RWE expertise and services to support regulatory evaluation and decision-making during the entire life-cycle of medicinal products, including vaccines. RWE activities performed by the workstream include:
• Liaising with EMA’s committees and working parties to identify RWE research needs, perform feasibility analyses and develop study protocols
• Conducting observational studies to provide RWE on the utilisation, safety and effectiveness of medicinal products
• Providing methodological advice to pharmaceutical companies on study designs, analytical methods and data sources used in RWE studies
• Developing, testing and using tools and learning material to support use of RWE, including innovative methods such as artificial intelligence and natural language processing
• Leveraging existing resources in Europe to identify, generate and use RWE supporting public health emergency response, including vaccine
• Developing and disseminating good practice for statistical and epidemiological methods applicable to use of RWE
• Overseeing the establishment and operation of the Coordination Centre for the Data Analytics & Real World Interrogation Network (DARWIN EU)
• Providing scientific coordination to the ENCePP network.
These activities are supported by a strong specialist team of data scientists, pharmacoepidemiologists, biostatisticians and administrators. Data sources include in house databases of primary health care and hospital care from France, Germany, Italy, Romania, Spain and the United-Kingdom, other data sources accessed via European research organisations through framework contracts and the DARWIN EU network, which will give access to a distributed data network of databases in Europe to allow the conduct of fast and high-quality studies supporting regulatory decision-making.
In order to further strengthen, develop and coordinate all RWE-related activities performed by the EMA and EMRN, the Agency is looking to recruit a Head of Real World Evidence, who will provide senior scientific leadership in the delivery of real world evidence expertise and services to EMA’s committees, EMA’s working parties the EMRN and EMA’s stakeholders.
In this post you will:
• Coordinate the implementation of the RWE-related activities in alignment with the strategic objectives of the EMA and EMRN and provide for high quality of the service outputs.
• Provide scientific leadership and promote methodological excellence on the generation, analysis, interpretation and use of RWE on drug utilisation, safety and effectiveness in the EU.
• Drive a programme of change to deliver RW data analysis into the core of medicines regulation in the EU.
• Stimulate innovation and promote the development, testing and use of new data sources (e.g. pharmacogenomic data), tools and methods for data analysis incl. those based on artificial intelligence.
• Manage and develop a team of 15-20 specialists, and coordinate the workstream’s technical and or/operational expertise and knowledge.
• Anticipate and lead necessary changes according to the Agency’s strategy, while ensuring the effectiveness and continuous improvement of the service and managing associated risks and issues.
Link to the full role description of the Head of Workstream outlining generic duties and responsibilities.
Apply if you have those eligibility criteria
General conditions:
1. Full rights as a citizen of an EU Member State or Iceland, Lichtenstein and Norway.
2. Thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2).
3. Fulfilled any obligations imposed by applicable laws concerning military service.
Specific conditions:
1. University degree of a minimum of four years in medicine, pharmacy, epidemiology, pharmacology, public health, statistics, or data science that must have been obtained by the closing date of this vacancy notice and relevant professional experience of at least 12 years obtained after the university degree, in the domain relevant to the Head of Workstream role.
or
University degree of three years in medicine, pharmacy, epidemiology, pharmacology, public health, statistics, or data science, and relevant professional experience of at least 13 years obtained after the university degree, in the domain relevant to the Head of Workstream role.
For general condition 1, 2, and for specific condition 1 it will be necessary to provide proof at the interview stage.
Only eligible candidates will be assessed by the selection committee in accordance with the assessment criteria below.
You will also need
Competencies you need to have
Role competencies
Applied Knowledge Management Intermediate
Continuous Improvement Intermediate
Core managerial competencies
Decision-making Basic
Coaching and Developing Advanced
Collaborative Team Leadership Basic
Inspiring and engaging Basic
Relating and networking Basic
Talent management Advanced
Visionary thinking and strategic planning Basic
Core competencies
Ethics and Integrity Intermediate
Team collaboration Advanced
Customer centricity Advanced
Results orientation Advanced
Communication Advanced
Cross-cultural sensitivity Advanced
Continuous learning and self-development Intermediate
Competencies form an important part of the assessment, and therefore, we advise you to refer to the EMA Competency Framework for more information about definitions of competencies and associated proficiency levels .
These are considered as nice to have:
