Scientist

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, 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.The EMP Department has two 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 and falsified(SF) medical products; and

 

 

(2) Access and Innovation which includes the Expert Committee of Selection and Use of Essential medicines, the Expert Committee on Drug dependence, work on national policies, procurement, supply management and pricing of health technologies as well as work on use of medicines including antimicrobials. In addition, work is carried out on public health, innovation and intellectual property including the Global Strategy and Plan of Action on Public health, Innovation and Intellectual property, and work on local production and transfer of technology.This position is within the Prequalification Team (PQT) of RHT.

DESCRIPTION OF DUTIES

Under the supervision of the Group Leader of the Vaccines Assessment group, the incumbent will have the following responsibilities\:

- Conduct the review of the manufacturers dossier submitted by manufacturers to support the prequalification evaluation of vaccines candidates for supply to United Nations agencies and coordinating 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. Evaluatesmanufacturing processes and procedures and reviews other relevant data on manufacturer premises. Confirm that the vaccines offered for supply comply with WHO technical standards, recommendations and UN tender specifications.

- Provide technical support 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 assess through feedback to PQT (and to the regulatory systems strengthening team staff), on the ability of the responsible National Regulatory Authorities 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.

- 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 immediate advice to WHO, UNICEF Supply, other UN agencies, the vaccine producers, regulatory authorities and immunization programme officials.

- Develop new 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 normal procedure and within three months internal target for 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 within the timeframe.

7. Participate in meetings with manufacturers and National Regulatory Authorities (NRAs) and provide guidance on the suitability (or not) of the development plans for vaccines currently under development.

8. Perform all other related duties as assigned.

REQUIRED QUALIFICATIONS

Education

Essential\: Advanced level university degree in Medicine, Biology, Microbiology or related science relevant to the area of work.
Desirable\: Specialization in microbiological sciences.

Experience

Essential\: At least seven years' 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 country or international level and/or with a National Regulatory Authority, with at least five years respective experience at the national level.
Desirable\: Experience at the international level. Familiarity with WHO prequalification procedure and experience in developing countries.

Skills

Solid scientific background, particularly in the area of vaccines. Extensive knowledge of production and quality control of vaccines. Understanding of Quality Systems. Expertise in and ability to work in a highly political international environment. Ability to manage a project.

WHO Competencies

Teamwork
Respecting and promoting individual and cultural differences
Communication
Ensuring the effective use of resources

Use of Language Skills

Essential\: Expert knowledge of English.
Desirable\: Intermediate knowledge of French.

REMUNERATION

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 71,332 (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 4434 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.

ADDITIONAL INFORMATION

• 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.

• For information on WHO's operations please visit\: http\://www.who.int.

• WHO is committed to workforce diversity.

• 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.