Under the authority of the Director of the EDQM and the Head of Division, the incumbent shall provide professional scientific assistance in accordance with procedures, guidelines and priorities with a concern for quality, efficiency, and accuracy and in compliance with the Council of Europe’s values and regulations.

Profile A

The incumbent performs all or a combination of the following duties:

-       evaluates requests for revision of applications for certificates of suitability to monographs of the European Pharmacopoeia and prepares draft reports for review by supervisors or external experts;

-       Ensures coherence between evaluation reports relative to other similar products and adherence to the respective quality systems or procedures;

-       communicates with applicants and prepares certificates;

-       works and communicates with supervisors, scientific officers in the Division and the rapporteurs assigned for the assessment of the dossiers.

Profile B

The incumbent performs all or a combination of the following duties:

-       takes charge of the validation of applications for certificates of suitability of the European Pharmacopoeia at receipt and checks their acceptability;

-       takes part in monitoring of dossiers and checks adherence to the respective quality systems or procedures;

-       communicates with applicants and prepares certificates;

-       works and communicates with supervisors, scientific officers in the Division and the rapporteurs assigned for the assessment of the dossiers.

Please note that the incumbent may be required to perform other duties not listed in the vacancy notice.

·      Qualifications: a completed university degree in pharmacy, chemistry, biochemistry or other relevant discipline. 

·      Experience:

-       PROFILE A: short professional experience (minimum 6 months and maximum 2 years) in the evaluation or in the preparation of dossiers on the quality of substances for pharmaceutical use, either in a licensing authority or in the industry.

-       PROFILE B: short professional experience (minimum 6 months and maximum 2 years) in the evaluation or in the preparation of dossiers on the quality of substances for pharmaceutical use, or in methods of synthesis or physicochemical analysis of pharmaceutical substances, obtained either in an authority or in the industry.

·      Language requirements: Very good knowledge of one of the official languages (English) in oral and written communication.

·      Nationality: must be a national of a Council of Europe member state.

·      Age: under 65 years of age, at the closing date of the vacancy notice. 

Please note that only applicants meeting the above-mentioned requirements will be considered for shortlisting. Moreover, these being only minimum requirements, there is no guarantee that applicants will be shortlisted, even if they meet all of these.

Essential:

For both profiles

·      Interpersonal skills: service and client orientation, team-work and co-operation.

·      Communication and linguistic skills: basic knowledge of the other language (French) required on appointment with the proviso that the level increases to good after appointment. 

·      ICT skills : sound computer skills of standard tools in office applications. 

·      Professional and technical competencies:

PROFILE A

-       knowledge of the pharmaceutical regulatory requirements;

-       planning and work organisation;

-       analytical thinking, problem-solving and judgement skills.

PROFILE B

-       knowledge of the pharmaceutical regulatory requirements;

-       planning and work organisation;

-       concern for quality.

Desirable:

·      ICT skills : Knowledge and experience of electronic Common Technical Document (eCTD) tools would be an advantage. 

·      Professional Competencies: information-seeking.

·      Personal attitudes: initiative and responsibility, sense of continuous improvement, concern for quality, efficiency and accuracy, self-management and development.

·      Personal values: discretion. 

For more information, please refer to the competency inventory of the Council of Europe.

Applications must be made in English or French using the Council of Europe on-line application system.  By connecting to our website http://www.coe-recruitment.com you can create and submit your on-line application.  Applications must be submitted at the latest 13 November 2013 (midnight Central European Time).  

The selection procedure may vary according to the specific requirements of the job vacancy. It consists of preliminary selection and can include ability tests, behavioural questionnaires, job related examinations, situational exercises, language tests, interviews and full assessment centres.

Depending on the number of applicants, the length of the required professional experience may be increased.  

Only candidates who best match the requirements of the job vacancy and, if applicable, candidates with the best results in the previous stages of the procedure (tests, exams, etc.) will, as a last stage of the procedure, be invited for an interview.

Following this competition, a list of eligible candidates, in order of merit, may be established. This list will be valid for two years with the possibility of extending it to a maximum of four years. During the period of validity of the list, candidates on the list may be offered employment of fixed term duration. It should be noted that placement on this list does not give candidates the right to an appointment within the Council of Europe. Moreover, the choice of candidates from a reserve list is not made solely according to the order of merit.  

The first year of employment will constitute a probationary period. Provided the staff members’ work is considered satisfactory, he/she may be offered  a contract of fixed term duration. However, the total length of employment will not exceed five years. The staff member so recruited shall not be eligible for any subsequent internal competition, promotion or transfer to a post, or for secondment. The compulsory retirement age is 65.

For the moment, this position is limited until 31 December 2014, and may be prolonged. 

Details on conditions of employment including salaries, allowances, pension scheme and social insurance can be consulted on our recruitment website. 

Under its equal opportunities policy, the Council of Europe is aiming to achieve parity in the number of women and men employed in each category and grade. In the event of equal merit, preference will therefore be given to the applicant belonging to the under-represented sex.

The Council of Europe welcomes applications from all suitably qualified candidates, irrespective of gender, disability, marital or parental status, racial, ethnic or social origin, colour, religion, belief or sexual orientation.

During the different stages of the recruitment procedure, specific measures may be taken to ensure equal opportunities for candidates with disabilities. 

The Organisation 

The Council of Europe is a political organisation founded in 1949 in order to promote greater unity between its members. It now numbers 47 member States. The Organisation’s main aims are to promote democracy, human rights and the rule of law, and to develop common responses to political, social, cultural and legal challenges in its member States. Since 1989 it has integrated most of the countries of Central and Eastern Europe and supported them in their efforts to implement and consolidate their reforms.

The Council of Europe has its permanent headquarters in Strasbourg (France). By Statute, it has two constituent organs: the Committee of Ministers, composed of the member States’ Ministers for Foreign Affairs, and the Parliamentary Assembly, comprising delegations from the national parliaments. The Congress of Local and Regional Authorities of Europe represents the entities of local and regional self-government within the member States.

The European Court of Human Rights is the judicial body competent to adjudicate complaints brought against a state by individuals, associations or other contracting states on grounds of violation of the European Convention on Human Rights.

The European Directorate for the Quality of Medicines & HealthCare (http://www.edqm.eu) is a leading organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use. Its standards are recognised as a scientific benchmark world-wide. The European Pharmacopoeia is legally binding in European member states.  Similarly, the EDQM develops guidance and standards in the areas of blood transfusion, organ transplantations and consumer health issues.  Its mission is to contribute to the basic human right of access to good quality medicines and healthcare and to promote and protect human and animal health.