Vacancy Notice N° e32/2015
CEP Scientific Assistants (Revisions’ Team) (Grade B4)
Directorate General of Democracy (DG II)
European Directorate for the Quality of Medicines & HealthCare (EDQM)
Certification of Substances Division (DCEP)
Location : Strasbourg
Under the authority of the Director of the European Directorate for the Quality of Medicines & Healthcare (EDQM) and the Head of Certification Division, 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.
The incumbent performs all or a combination of the following duties:
· Participates in the scientific evaluation of dossiers submitted for revision in respect of existing certificates of suitability to the monographs of the European Pharmacopoeia in accordance with technical rules and guidelines (general and specific monographs of the European Pharmacopoeia, guidelines adopted by the Steering Committee and the Technical Advisory Boards of the Certification procedure, guidelines of the European Medicines Agency);
· Manages assigned dossiers in accordance with established rules and procedures; reports to the supervisor on the status and progress of activities and if and when problems occur;
· Ensures consistency of assessment reports for similar products and consistency of the reports with the policy of the procedure, if necessary analysing and reporting any discrepancies and proposing solutions;
· Prepares reports for review by supervisors or external experts, drafts correspondence and certificates, and communicates with applicants;
· Participates in the maintenance and improvement of the EDQM’s quality management system and the maintenance of the ISO 9001 certificate for Certification 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: completed higher education degree or qualification in pharmacy, chemistry, biochemistry or other relevant discipline.
· Experience: short professional experience (minimum 6 months) in the evaluation or in the preparation of dossiers on the quality of substances for pharmaceutical use (CTD Module 3.2.S), either in a licensing authority or in the industry.
· Language requirements: very good knowledge of one of the official languages (English) in oral and written communication; basic knowledge of the other official language (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.
– Professional and technical competencies:
– knowledge of the European regulatory requirements in the field of pharmaceuticals;
– planning and work organisation;
– analytical thinking; problem-solving; judgement skills; concern for quality, efficiency and accuracy.
· Interpersonal skills: service and client orientation, team-work and co-operation.
· ICT skills : sound computer skills of standard tools in office applications.
· 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; results orientation and sense of continuous improvement; self-management and development.
· Personal values: discretion.
Applications must be made in English or French using the Council of Europe on-line application system. By connecting to our websitewww.coe.int/jobs you can create and submit your on-line application. Applications must be submitted at the latest 7 April 2015 (midnight Central European Time).
The selection procedure consists of a shortlisting based on candidates’ applications and may include ability tests, behavioural questionnaires, a job related written exam, situational exercises, language tests, interviews and full assessment centres.
Only candidates who best match the requirements of the job vacancy will be shortlisted and invited to test or a written exam. Tests or written exams may be eliminatory, in which case only candidates who succeed in the tests will be invited for interview. Depending on the number of applicants, the length of the professional experience considered for shortlisting may be increased from that indicated in the vacancy notice.
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. 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.
For the moment, the duration of the position is limited to 31 December 2015, but may be prolonged.
Details on conditions of employment including salaries, allowances, pension scheme and social insurance can be consulted on our recruitment website.