SCIENTIST (HQ/14/HSS/FT129)

27 July 2016
 
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The mission of WHO is the attainment by all peoples of the highest possible level of health.
Vacancy Notice No: HQ/14/HSS/FT129
 
Title: Scientist
 
Grade: P4
 
Contract type: Fixed-term Appointment
 
Duration of contract:  1 year
 
Date: 17 March 2014
 
Application Deadline: 7 April 2014 Vacancy Filled
 
Duty Station:  Geneva, Switzerland
 
Organization unit:
HQ/PQT Prequalification Team (HQ/PQT)
 
OBJECTIVES OF THE PROGRAMME :
To ensure access to high quality vaccines for National Immunization Programmes through the timely and adequate establishment of norms and standards, the prequalification of vaccines for purchase by UN agencies, strengthening national regulatory capacity both in the short and long-term and the assessment of vaccine safety issues at global level.
Description of duties:
Under the general supervision of the Group Lead, Vaccines Assessment in the Prequalification Team (PQT), the incumbent is responsible for:
- Coordinating the review of the clinical trial data submitted by manufacturers to support the prequalification evaluation of vaccines candidates for supply to UN agencies and for coordinating the review of updated clinical (efficacy and safety) information to be submitted by manufacturers at the time of reassessment of already prequalified vaccines.
- Following up with manufacturers of recently prequalified combinations and novel vaccines on the timely submission of post-prequalification clinical study commitments, and to coordinate the review of such data.
- Providing consolidated reports of the reviews with an opinion on the acceptability, or not, of the available information and responsibility for coordinating the review of any complementary information or additional studies that may be required.
- Creating and updating documents providing additional guidance to WHO clinical reviewers on the scope of the review and specific aspects that need to be considered to assess the suitability of the vaccine/s for the UN agencies target populations, with a view at harmonizing the review by different assessors.
- Assisting in developing a procedure/setting criteria for confirming Good Clinical Practice (GCP) (i.e inspections).
- Developing specific guidance based on the WHO Clinical Guidelines on potential protocol design for clinical evaluation of combination vaccines, rotavirus, HPV and other novel vaccines and/or novel delivery systems.
- Giving advice to manufacturers approaching WHO to request orientation on the suitability of the proposed protocols for trials.
- Ensuring that the evaluation of the clinical package is performed within the established time frame to ensure that the total timeframe for evaluation of a candidate vaccine does not exceed a set by management timeframe (e.g. total of 18 months including timeframe taken by manufacturers for providing responses, samples etc.).
- Contributing to assessment through feed back to the Vaccine Regulation staff, on the ability of the responsible National Regulatory Authorities to oversee the conduct of clinical trials and to evaluate clinical trial data.
- Feeding the vaccine quality data base with the relevant clinical information for each vaccine that is prequalified.
- Participating in evaluation and responding to incidents of vaccine related complaints. Providing 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 participates in providing immediate advice to WHO, UNICEF Supply, other UN agencies, the vaccine producers, regulatory authorities and immunization programme officials. Assisting in developing systems for investigation and analysis of such problems, formulating appropriate responses and preparing information documents on their resolution.
- Providing expert technical advice on the clinical performance of vaccines with the focus on pre-qualified vaccines (efficacy and safety).
- Identifying training needs and contributing to the development of appropriate training curricula to be provided through GTN or other mechanisms.
- Contributing to the update of the Procedure for assessing the acceptability, in principle, of vaccines for purchase through UN agencies.
- Undertaking other duties as assigned by the Group Lead, PQT Vaccines Assessment and the PQT Coordinator.
REQUIRED QUALIFICATIONS
Education:
Essential:
University degree in Medicine Biology, Microbiology or related science with postgraduate degree in Epidemiology with focus on infectious diseases.

Desirable:
Training in biostatistics.
Skills:
Solid clinical scientific background, particularly in the area of infectious diseases and vaccines.
Extensive experience in the design, monitoring and evaluation of clinical trials for vaccines.
Understanding of Quality Systems.
Experience in and ability to work in a highly political international environment.
Ability to manage a project.

Other skills:
Ability to use computer techniques, particularly the Microsoft package of programmes.
Good professional writing skills.

WHO competencies:
Producing results
Fostering integration and teamwork
Communicating in a credible and effective way
Setting an example
Experience:
Essential:
Considerable experience of no less than 7 years in the field of infectious diseases, immunization and regulation of biological products including vaccines acquired by working in the field of immunization or community and preventive medicine at country or international level and/or with a National Regulatory Authority, with at least 5 years respective experience at the national level.

Desirable:
Experience at the international level a distinct asset. Familiarity with the 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 along with work experience in developing countries.
Languages:
Expert knowledge of English required. Intermediate knowledge of French an asset.
Additional Information:
Other similar positions at the same level may be filled from this vacancy notice.
A written test may form part of the screening process.
This Vacancy Notice is published in English only.
Annual salary: (Net of tax)
USD 67611 at single rate
USD 72605 with primary dependants
Post Adjustment: 103.3 % 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.

Online applications are strongly encouraged to enable WHO to store your profile in a permanent database. Please visit WHO's e-Recruitment website at: www.who.int/employment. 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.

Vacancy Filled

This vacancy is shown for viewing only. It is not currently open for applications
 
 
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