FIXED-TERM CONTRACT

Under the authority of the Director of the European Directorate for the Quality of Medicines & Healthcare (EDQM) and the Head of Certification Division, and under the supervision of the Head of the New Dossiers section, the incumbent shall provide professional scientific assistance to the procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) 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.

* External recruitment procedure organised in accordance with Article 15B of the Regulations on Appointments

The incumbent performs the following key duties:

• participates in the scientific assessment of new applications for certificates of suitability (CEPs)  for pharmaceutical substances, in accordance with the rules and guidelines (including the monographs of the European Pharmacopoeia, EU pharmaceutical legislation and guidelines, as well as EDQM specific policies);
• provides support to expert assessors from national competent authorities reviewing new applications for CEPs; prepares reports, documents, files, etc.  and takes part in scientific discussions with external experts or advisory boards with the aim of achieving a consensus;
• ensures consistency of evaluation reports, ensures that the reports are elaborated in line with the policies of the procedure, the rules and guidelines in place, and if necessary analysing and reporting any discrepancies and proposing solutions;
• communicates with applicants; ensures appropriate monitoring for allocated dossiers;
• takes part and reviews proposals for technical guidelines and policies, for approval by the relevant technical boards;
• takes part in the maintenance of the Quality Management System within the Division; and the maintenance of the ISO 9001 certificate for related activities.

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

Only applicants who best meet the following criteria will be considered for shortlisting.

Qualifications:

›          Higher education degree or qualification in pharmacy, chemistry, biochemistry or other relevant discipline. 

Experience:

›          at least 4 years' professional experience including at least 2 years' proven experience  in the evaluation or compilation of the quality part of dossiers submitted with marketing authorisation applications of medicines (with a focus on Module 3.2.S of the CTD), either in a national competent authority or in the pharmaceutical or chemical industry; 

Language requirements:

›          Very good knowledge of one of the official languages (English) and basic knowledge of the other (French). 

Nationality:

›          Nationality of one of the 47 Council of Europe member states. 

Age:

Under 65 years of age at the closing date of the vacancy notice.

Council of Europe staff members adhere to the values Professionalism, Integrity and Respect.

Essential:

• Professional and technical expertise

-        knowledge of the European regulatory requirements in the field of the quality of medicinal products; 

›          Planning and work organisation

›          Analysis and problem solving

›          Concern for quality

›          Service orientation

›          Teamwork and co-operation

›          Relationship building

Desirable: 

›          Results orientation

›          Learning and development

For more information, please refer to the Competency Framework 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 www.coe.int/jobs you can create and submit your on-line application.  Applications must be submitted at the latest  22 February 2016 (midnight Central European Time).

The selection procedure consists of shortlisting, assessment(s), and a panel interview.  Assessments may include one or more of the following: ability tests, behavioural questionnaires, job-related examinations, situational exercises, language tests, interviews and full assessment centres. At least one assessment will be eliminatory.

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

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 with a panel.

Following this competition, a reserve list of successful 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. It should be noted that placement on a reserve list does not give candidates the right to an appointment within the Council of Europe.  The choice of candidates from a reserve list is not made solely according to the order of merit but also takes into account the requirements of the position to be filled and the qualifications of the candidates.

During the period of validity of the reserve list, candidates on the list may be offered employment on a fixed-term contract, which may be renewed one or several times. There is a statutory probationary period of two years.

The compulsory retirement age is 65.

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 the continent’s leading organisation in the protection of human rights, democracy and rule of law. It was founded in 1949 in order to promote greater unity between its members  and  now includes 47 member states, all having signed up to the European Convention on Human Rights.

By Statute, the Council of Europe 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 Commissioner for Human Rights is an independent and impartial institution within the Council of Europe mandated to promote the awareness of and respect for human rights in member states.

The European Court of Human Rights is the judicial body which oversees the implementation of the Convention in the member states. Individuals can bring complaints of human rights violations to the Strasbourg Court once all possibilities of appeal have been exhausted in the member state concerned.

The Council of Europe has its permanent headquarters in Strasbourg (France) and in addition it maintains external presence in more than twenty countries. More information about the Council of Europe external presence.

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.