Scientific Programme Officer – Council of Europe

Vacancy Notice N° e13/2016

Scientific Programme Officer (Assessor) (Grade A1/A2)
Directorate General of Democracy (DG II)
European Directorate for the Quality of Medicines & HealthCare (EDQM)

Certification of Substances Division (DCEP)

Job Mission

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

Key activities

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.

Closing date: 22 February 2016
Location : Strasbourg, France

Read more and apply here.