Scientist (Vaccines Assessment)

Geneva | Geneva

OBJECTIVES OF THE PROGRAMME : The Department of Essential Medicines and Health Products (EMP) 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. The EMP department works with the HIS cluster departments in the wider framework of Universal Health Coverage and category 4 of the Global programme of Work, and cooperates with disease oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, noncommunicable diseases (NCDs) and mental health) towards the Millennium Development Goals. The department works with a wide range of United Nations (UN) organizations, international partners and expert networks, and WHO Collaborating Centres.The department has three large areas of work:(1) Regulation of Medicines and other Health Technologies (RHT) unit (covering medicines, vaccines, other biologicals, blood products, medical devices and diagnostics), which consists of four teams covering the normative and standard setting work, the prequalification of medicines, vaccines and diagnostics for UN and international procurement, the strengthening of regulatory systems and networks, and the safety and vigilance of health technologies. RHT is also responsible for work on detection and prevention of substandard/spurious/falsely labelled/falsified/counterfeit (SSFFC) medical products.(2) Policy,Access and Use team, which includes the Expert Committee of Selection and Use of Essential medicines, and the Expert Committee on Drug dependence, and covers the work on national policies, procurement, supply management and pricing of health technologies.(3) Public Health, Innovation and Intellectual Property team which covers the Global Strategy and Plan of Action on Public health, Innovation and Intellectual property, works with countries on local production and transfer of technology approaches; and on strategies for management of intellectual property issues.The objective of the Prequalification Team (PQT) in RHT is to enhance access to health technologies (medicines, vaccines, diagnostics and devices) of appropriate levels of quality, safety and efficacy for priority diseases. Description of duties: The incumbent works in the Vaccines Assessment Group within the Prequalification Team (PQT). Under direct supervision of the Group Lead, Vaccines Assessment, the incumbent will:- participate in the evaluation of the quality, safety and efficacy of vaccines offered for supply through UN purchasing agencies,- evaluate the suitability of candidate vaccines for use in National Immunization Programmes,- contribute to the reliability of producing countries regulatory authorities to oversee the quality of the vaccines; and- provide technical and scientific advice on issues related to the acceptability of vaccines supplied.Under the general supervision of the Group Lead, Vaccines Assessment PQT, the incumbent will have the following responsibilities:- Coordinate and participate in the review of the dossiers submitted by manufacturers to support the prequalification evaluation of vaccine candidates for supply to United Nations agencies and for coordinating and participating the review of updated information to be submitted by manufacturers at the time of reassessment of already prequalified vaccines.- Provide advice to the Group Lead on the acceptability in principle of vaccines proposed for purchase. Evaluate manufacturing processes and procedures and review other relevant data on manufacturer premises. Confirm that the vaccines offered for supply comply with WHO recommendations and UN tender specifications.- Provide technical advice to the procurement arms of the UN agencies concerning prequalification criteria, specifications, packaging materials and other terms and conditions for the international procurement and supply of vaccines.- Contribute to the assessment, through feedback to the Prequalification Secretariat (and to the National Regulatory Authority (NRA) systems strengthening staff), on the ability of the responsible NRA to oversee the vaccines. - Prepare the Vaccine Public Assessment Summary Reports (VPASR) for publication on the website for each vaccine that is prequalified.- Review the Prequalified Vaccines Annual Reports (PQVARs) submitted by the manufacturers of prequalified vaccines within the timeframe of the contract.- On behalf of WHO, evaluate and respond to incidents of vaccine related complaints. Provide technical advice regarding complaints or requests for assistance from the field relating to vaccine efficacy, adverse reactions or other events which might compromise the acceptability, in principle, of vaccines that are pre-qualified, and provide prompt advice to WHO, UNICEF Supply, other UN agencies, the vaccine producers, regulatory authorities and immunization programme officials.- Develop systems for investigation and analysis of such problems, formulating appropriate responses and preparing information documents on their resolution.- Identify training needs and contribute to the development of appropriate training curricula to be provided through Global Learning Opportunity (GLO) or other mechanisms.- Undertake other duties as assigned by the Coordinator of PQT.Deliverables:1. Timely production of consolidated (from a minimum of two reviewers) assessment reports as part of the prequalification evaluation process (as per published Prequalification procedure WHO TRS 978, Annex 6). Completion of the evaluation process within nine months internal target for the normal procedure and within three months internal target for the streamlined procedure.2. Timely review of additional data submitted by manufacturers as post-prequalification commitments.3. Review of all the package inserts submitted by manufacturers within the timeframe of the contract.4. Timely development of Vaccine Public Assessment reports (VPASR) for publication on the website at the time of prequalification of a vaccine product.5. Investigation of reports of adverse event following immunization (AEFI) or complaints that may be linked to the clinical performance of prequalified vaccines.6. Review all the Prequalified vaccine annual reports (PQVARs) submitted by manufacturers of prequalified vaccines during the timeframe of the evaluation.7. Participate in meetings with manufacturers and NRAs and provide guidance on the suitability (or not) of the development plans for vaccines currently under development. REQUIRED QUALIFICATIONS Education:Essential:An advanced university degree (Masters level or above) in Medicine, Biology, Microbiology or related science.Desirable:Formal training in biostatistics.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: Some professional certificates may not appear in the WHED and these will be reviewed individually. Skills: Solid scientific background, particularly in the area of infectious diseases and vaccines. Extensive knowledge of production and quality control of vaccines. Understanding of Quality Systems. Proven ability to work in a highly political international environment. Ability to manage a project.Ability to use computer techniques, particularly Microsoft package of programmes. Good professional writing skills.WHO Competencies:1. Ensuring the effective use of resources2. Communicating in a credible and effective way3. Fostering integration and teamwork4. Respecting and promoting individual and cultural differences Experience: EssentialAt least seven years of experience in the field of immunization and regulation of biological products including vaccines, acquired by working in the field of immunization or community and preventive medicine at both country and international level including five years of experience with National Regulatory Authority (NRA).DesirableFamiliarity with WHO prequalification procedure, with WHO activities in strengthening the capacity to regulate clinical trials and/or with the NRA assessment procedure would be an asset. Work experience in developing countries. Languages: Essential:Expert knowledge of English.Desirable:Intermediate 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:, to learn more about WHO's operations, click on: Quick Links > Salary Scales > by date. Post Adjustment: 89.2 % of the above figure(s). This percentage is to be considered as indicative since variations may occur each month either upwards or downwards due to currency exchange rate fluctuations or inflation. This vacancy notice may be used to fill other similar positions at the same grade level. A written test and interviews may be used as a form of screening Online applications are strongly encouraged to enable WHO to store your profile in a permanent database. Please visit WHO's e-Recruitment website at: The system provides instructions for online application procedures. All applicants are encouraged to apply online as soon as possible after the vacancy has been posted and well before the deadline stated in the vacancy announcement. WHO is committed to workforce diversity. Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual. Only candidates under serious consideration will be contacted. Currently accepting applications
Before applying, please make sure that you have read the requirements for the position and that you qualify.
Applications from non-qualifying applicants will most likely be discarded by the recruiting manager.
  • Organization: WHO - World Health Organization
  • Location: Geneva | Geneva
  • Grade: P-4, International Professional
  • Occupational Groups:
  • Closing Date: 2015-11-24

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