Senior Project Officer SoHO - Serious Adverse Reactions and Events

The European Directorate for the Quality of Medicines & Healthcare (EDQM) is a leading organisation whose mission is to contribute to public health protection by engaging with an international community of experts and stakeholders. We achieve this by promoting acces to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific bookmark worldwide. The EDQM's standards for medicines and their ingredients, compiled in the European Pharmacopeia, are legally binding in its 39 member states (and the European Union) and are also widely used across the globe in the human and animal health sectors. The EDQM also plays a crucial role in the areas of blood transfusion, organ, tissue and cell transplantation and in developing and setting consumer health standards, such as for cosmetics and food contact materials.

The team within which you will work is the Substances of Human Origin (SoHO) Standards Section in the SoHO Division. This section provides the secretariat for various activities such as the Blood, Organs and Tissues and Cells Guides, as well as for other topics such as biovigilance, in co-operation with the European Commission (EC).

As a Senior Project Officer in the Substances of Human Origin (SoHO) team, your role will focus on biovigilance activities including the following tasks:

• consolidating and analysing data from the EC’s annual Serious Adverse Reactions and Events (SARE) exercise, and reporting and presenting it to DG SANTE (EC) and national competent authorities;
• actively participating in European biovigilance projects impacting EDQM activities; 
• liaising with stakeholders (including representatives from member states, professional associations and international bodies), especially the vigilance working group of the EC’s SoHO Coordination Board (SCB);
• supporting the co-ordination of other data collection/analysis activities;
• drafting and/or co-ordinating the drafting of reports, scientific documents and guidelines; 
• participating in the organisation and preparation of relevant events in the area of biovigilance, including presentations and other materials; 
• promoting the Division’s activities, while keeping abreast of developments in the SoHO field;
• helping to prepare the budget for the abovementioned activities and reporting on progress made.

• Operational - Planning and work organisation
• Operational - Drafting skills
• Operational - Concern for quality
• Interpersonal - Teamwork and co-operation

• Professional and technical expertise:

  • knowledge of biological principles of human application of SoHO ;

  • knowledge of the biovigilance approach ;

  • advanced knowledge and use of Excel.

• Operational - Results orientation
• Interpersonal - Initiative

• Professional and technical expertise:

• familiarity with EU annual SoHO SARE reporting system, especially Common Approach; 

• experience in implementation of biovigilance-related EU Directives. 

This job vacancy is for an international external recruitment. You can consult the conditions of employment (salaries, allowances, pension scheme, social insurance, etc.) on the webpage What we offer. 

For more information on how we recruit, you can consult the page Our recruitment process. This recruitment is carried out in accordance with Article 490 of the Council of Europe Staff Rules. The deadline for applications is indicated in the General information section of this vacancy notice (see above) and is fixed at 23:59:59 (CET/CEST). When applying, make sure your motivation shows how your competencies make your profile the best for the role.

As an equal opportunity employer, the Council of Europe welcomes applications from all suitably qualified people, irrespective of sex, gender, sexual orientation, ethnic or social origin, disability, religion or belief. Under its equal opportunity policy, the Council of Europe is aiming to achieve gender parity in staff employed in each category and grade. At the time of appointment, preference between suitable people shall be given to the person of the gender which is under-represented in the relevant grades within the category to which the vacancy belongs.

Applicants with specific needs are encouraged to request reasonable accommodations at any stage during the recruitment process. Please contact us at [email protected], we will ensure that your request is handled.

The information published on the CoE’s careers website regarding working conditions is correct at the time of publication of the vacancy notice. Any changes to these conditions during the recruitment process will be updated on our Portal and will apply at the time of the job offer. Our career's website is not intended to be exhaustive and may not address all questions you would have. Should you have remaining questions, please contact us at [email protected].