WHO ROE Copenhagen
( 1904955 )
Grade : P4
Contractual Arrangement : Fixed-term appointment
Contract duration : Two years
Job Posting: Nov 27, 2019, 10:00:40 AM
The Regulation of Medicines and other Health Technologies unit (RHT) works with Member States and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. RHT works within the Access to Medicines, Vaccines and Pharmaceuticals (MVP) cluster departments in the wider framework of Universal Health Coverage and category 4 of the General Programme of Work and cooperates with disease oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Sustainable Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres.
DESCRIPTION OF DUTIES
- Coordinates the liaison between WHO and UNICEF in relation to the prequalification of Medical products and other Heath Technologies;
- Advises the Group Lead in planning, management and coordination of assessments carried out in the WHO Prequalification Team’s Medicines Assessment group;
- Provides technical assessment and evaluation of submitted dossiers from pharmaceutical manufacturers with respect to quality;
- Liaises and communicates with pharmaceutical manufacturers on dossiers submitted for prequalification;
- Develops, maintains and enhances standard operating procedures, guidelines and related quality assurance systems for PQT;
- Provides expert advice on technical issues related to quality issues of medicine as well as providing technical expertise in relevant meetings and Expert Advisory groups;
- Manages the reception, storage and general organization of the product dossiers of PQT, stored at the UNICEF offices in Copenhagen and make available the dossiers to other assessors and inspectors, for example for the assessment weeks organized by WHO.
- Essential: An advanced university level degree (masters level or above) in pharmaceutical sciences, or related field.
- Essential: At least seven years of national/international working experience in a national regulatory agency as an assessor of the quality part of the dossier or related professional experience with in depth knowledge and hands-on experience of dealing with the pharmaceutical quality aspects of marketing authorizations.
- Desirable: Experience in the administration and management of quality management systems.
- Comprehensive knowledge of medicines regulation with special emphasis on the assessment of the quality part of the marketing authorization dossiers.
- In-depth knowledge of WHO quality standards for pharmaceutical products and international regulatory requirements for marketing authorization of medicinal products.
- Knowledge of quality management systems.
- Good professional drafting and communication skills.
- Expertise in working together with other regulatory experts.
- Ability to work under time pressures.
- Respecting and promoting individual and cultural differences
- Producing results
- Knowing and managing yourself
Use of Language Skills
- Essential: Expert knowledge of English.
- Desirable: Beginners knowledge of French.
WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 60,233 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 2756 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.
- This vacancy notice may be used to fill other similar positions at the same grade level
- Only candidates under serious consideration will be contacted.
- A written test may be used as a form of screening.
- In the event that your candidature is retained for an interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
- Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.
- Staff members in other duty stations are encouraged to apply.
- For information on WHO’s operations please visit: http://www.who.int.
- WHO is committed to workforce diversity.
- WHO’s workforce adheres to the WHO Values Charter and is committed to put the WHO Values into practice.
- WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
- WHO has a mobility policy which can be found at the following link: http://www.who.int/employment/en/. Candidates appointed to an international post with WHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world.
- Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
- *For WHO General Service staff who do not meet the minimum educational qualifications, please see e-Manual III.4.1, para 220.