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Qualifications

Purpose of consultancy

The consultant shall work in coordination with the Vaccines and Immunization Devices Assessment Prequalification Team (PQT) focal points:

• To review the quality (CMC) of specific vaccines to ensure that they fulfil the requirements as indicated in the relevant WHO and other international standards.
• To raise queries in case of incomplete data and assess the adequacy of the manufacturers’ responses.
• To make a recommendation based on the adequacy of the vaccine as per the acceptability of the WHO vaccine prequalification dossier (VPQD) in principle for purchase by UN agencies.

In order to fulfill the purpose, the consultant should:

• Assess what published guidelines, requirements/recommendations, and international guidance documents are available from WHO and other regulatory agencies that are relevant for the evaluation of a vaccine.

All recommendations by the consultant are advisory to WHO, who retains full control over any subsequent decisions and actions, including whether to publish the findings and recommendations to accept the vaccine for acceptability in principle for purchase by UN agencies.

Background

The World Health Organization (WHO), through its Regulation and Prequalification Department provides advice to the United Nations Children’s Fund (UNICEF) and other United Nations agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies. This service is called prequalification.

The purpose of the WHO prequalification assessment is to provide assurance that candidate vaccines: (a) meet WHO recommendations on quality, safety and efficacy, including compliance with WHO’s recommended standards for good manufacturing practices (GMP) and good clinical practice (GCP); and (b) meet the operational packaging and presentation specifications of the relevant United Nations agency. Prequalification also supports the specific needs of national immunization programmes with regards to vaccine characteristic such as potency, thermostability, presentation, labelling and shipping conditions.

The aim is to ensure that vaccines provided through the United Nations for use in national immunization services in different countries are safe, effective and suitable for the target populations at the recommended immunization schedules and with appropriate concomitant products.

This important work is carried out with the support of international experts in Non-Clinical, Clinical and Chemistry, Manufacturing and Controls (CMC) evaluation of biological medicinal products, specifically vaccines. WHO is making a call to increase the number of consultants/experts available to support this very important public health responsibility.

Deliverables

• Produce timely assessment reports (AR) of the reviewed information.
• Report on critical, major, and other deficiencies detected during the review of the documentation/data (assigned to the consultant)
• Assess the applicant’s responses to queries raised in the AR and decide on the adequacy of each response. Several sets of queries may be necessary.
• Provide WHO with a recommendation and final remarks on the evaluation based on the documentation assigned for review to the consultant. This should be based on the most updated scientific and regulatory grounds.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced university degree in medicine, biology, pharmacy or microbiology.

Desirable:

• A postgraduate degree in biostatistics.

Experience

Essential:

• Over ten years’ experience in the pharmaceutical field.
• Extensive experience in the area of CMC of vaccines including the understanding of Quality Systems.
• Experience in the regulation, manufacturing and control of vaccines, and ability to work in a complex international environment.
• Experience in monitoring of regulations and regulatory systems of NRAs, including lot release, manufacture and laboratory good practices, laboratory access, post-marketing surveillance (quality aspects) and other activities like writing regulatory procedures.

Desirable:

• Participation in WHO evaluations of NRA and vaccine manufacturers as well as in other WHO activities.

Skills:

Essential:

• Expert must have technical skills and knowledge on the development, strengthening and monitoring of regulatory systems for vaccines, drugs, biologicals, and medical devices.

Desirable:

• Familiarity with WHO prequalification procedure, with WHO activities in strengthening the capacity to regulate clinical trials, vaccines as a biological medical product and /or with the NRA assessment procedure.

Languages required:

Essential:

• Expert knowledge of English.

Location

Off site: Home-based.

Travel

The consultant is not expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level C: USD 500 – 625 per day.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

Contract duration varies based on the programme needs.

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for 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.
• For information on WHO’s operations please visit: http://www.who.int.
• The WHO is committed to creating a diverse and inclusive environment of mutual respect. The WHO recruits workforce regardless of disability status, sex, gender identity, sexual orientation, language, race, marital status, religious, cultural, ethnic and socio-economic backgrounds, or any other personal characteristics.
  The WHO is committed to achieving gender parity and geographical diversity in its workforce. Women, persons with disabilities, and nationals of unrepresented and underrepresented Member States (https://www.who.int/careers/diversity-equity-and-inclusion) are strongly encouraged to apply for WHO jobs.
  Persons with disabilities can request reasonable accommodations to enable participation in the recruitment process. Requests for reasonable accommodation should be sent through an email to reasonableaccommodation@who.int.
• An impeccable record for integrity and professional ethical standards is essential. WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter (https://www.who.int/about/who-we-are/our-values) into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of short-listed candidates.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority.
• WHO shall have no responsibility for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Please note that WHO’s contracts are conditional on members of the workforce confirming that they are vaccinated as required by WHO before undertaking a WHO assignment, except where a medical condition does not allow such vaccination, as certified by the WHO Staff Health and Wellbeing Services (SHW). The successful candidate will be asked to provide relevant evidence related to this condition. A copy of the updated vaccination card must be shared with WHO medical service in the medical clearance process. Please note that certain countries require proof of specific vaccinations for entry or exit. For example, official proof /certification of yellow fever vaccination is required to enter many countries. Country-specific vaccine recommendations can be found on the WHO international travel and Staff Health and Wellbeing website. For vaccination-related queries please directly contact SHW directly at shws@who.int.
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For roster VNs:

The purpose of this vacancy is to develop a list of qualified candidates for inclusion in this advertised roster. All applicants will be notified in writing of the outcome of their application (whether successful or unsuccessful) upon conclusion of the selection process. Successful candidates will be placed on the roster and subsequently may be selected for consultancy assignments falling in this area of work or for similar requirements/tasks/deliverables. Inclusion in the Roster does not guarantee selection to a consultant contract. There is no commitment on either side.

Level of Education: Bachelor Degree

Work Hours: 8

Experience in Months: No requirements