| OBJECTIVES OF THE PROGRAMME : To optimize WHO's technical advice and political support to Member States by developing and promoting norms, standards and guidelines for quality, safety, rational use and efficacy of medicines. | |
| Description of duties: The incumbent will participate in the daily management and development of the quality assessment activities of the WHO Prequalification Programme, ensuring timely prequalification of priority medicines with the involvement and support from the national medicines regulatory authorities. Assess quality-related aspects of submissisons from applicants for prequalification of medicinal products and to communicate with applicants. Participate in planning, management and coordination of assessments carried out in the WHO Prequalification for Medicines Programme . Provide technical assessment and evaluation of submitted dossiers from pharmaceutical manufacturers with respect to quality. Manage, coordinate and monitor assessment done by internationally based assessors. Liaise, coordinate and communicate with pharmaceutical manufacturers on dossiers submitted for prequalification. Create and maintain standard operating procedures, guidelines and related quality assurance systems for the prequalification programme. Provide expert advice on technical issues related to quality issues of medicine as well as providing technical expertise in relevant meetings and Expert Advisory groups. | |
| REQUIRED QUALIFICATIONS | |
| Education: Essential First level university degree in Pharmacy with a Masters level university degree in Pharmacy or Pharmaceutical Technology. WHO only considers higher educational qualifications obtained from an accredited institution. | |
| Skills: 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 andinternational regulatory requirements for marketing authorization of medicinal products. Knowledge of quality management systems. Good professional drafting and communication skills. Experience in working together with other regulatory experts. Ability to work under time pressure. WHO competencies 1. Knowing and managing yourself 2. Producing results 3. Communicating in a credible and effective way | |
| Experience: 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 indepth knowledge and hands-on experience of dealing with the pharmaceutical quality aspects of marketing authorizations. Experience in the administration and management of quality management systems. Desirable Experience in working in the international regulatory environment. | |
| Languages: Essential Expert knowledge of English. Desirable Beginners knowledge of French. | |
| Additional Information: This vacancy is published in English only. 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. WHO's salaries are calculated in US dollars. They consist of a base salary and a post adjustment, which reflects the cost of living in a particular duty station and exchange rates. Other benefits include: 30 days annual leave, family allowance, home travel, education grant for dependent children, pension plan and medical insurance. Please visit the following websites for detailed information on working with WHO: www.who.int, to learn more about WHO's operations icsc.un.org, click on: Quick Links > Salary Scales > by date. |
