Consultant - Research and development, clinical trials, ethics, regulatory safety, and pharmacovigilance (AVAREF program)

IMPORTANT NOTICE: Please note that the deadline for receipt of applications indicated above reflects your personal device's system settings.

1. Background and Justification AVAREF, AdVancing ClinicAl TRials Excellence in AFrica, is a network of NRAs and NECs established 20 years ago by the WHO with its primary mission for capacity building of the NRAs and NECs. AVAREF is leveraging its strong network of NRAs and NECs and associated platform to enhance vaccine research and development through excellence in clinical trials. The AVAREF Secretariat situated within Vaccine Research and Innovation Unit (VRIU) within the Vaccine Preventable Diseases (VPD) Program is responsible for delivering on the workplan for a wide range of activities including capacity building initiatives, technical assistance to member states, and coordination of programs with partners and stakeholders. In the last 2 decades, since 2006, AVAREF has achieved a great deal and been involved in the attainment of major milestones for the clinical trial ecosystem. AVAREF has over the years been instrumental in facilitating research and development through clinical trials by the increase in maturity levels for NRAs (currently 8 out of the 48 member states in the region); use of the AVAREF platform to support the registration of emergency use vaccines for Ebola, COVID-19, and Mpox; supporting the clinical development, clinical trials, and approvals of key public health vaccines, including RTS,S (malaria), meningitis (Neisseria meningitidis and Streptococcus pneumoniae), Ebola, rotavirus, pneumonia, Covid-19, cholera, and cervical cancer; contributing to capacity building and strengthening for a wide range of reviewers within NRAs – training 120 individuals in 2024; and 67 specialists in 2025; all making AVAREF a globally recognized model of regulatory harmonization and excellence on the continent. AVAREF has been implementing its 2024-26 Strategic Operational and Action Plan which contains 3 main pillars (partnerships for results, trusted expert support, and life cycle approach) on which its main activity of excellence in capacity building rests and developing a 10 year (2025-35) Strategic Plan of Action. The landscape (or ecosystem) within which AVAREF operates has changed significantly in the last 2 decades with 8 member states attaining maturity level 3 (ML3) with others in line. AVAREF deals not only with vaccines but all therapeutic products. AVAREF finds itself within a highly competitive environment which requires hard transformations to respond to drastic funding reductions, an increasing number of well-funded organizations with similar mandates (namely Africa CDC and AMA), donors streamlining their funding. In response, AVAREF is transforming from a Secretariat to a program through building on its existing core body of work such as development of norms and standards for clinical trials, capacity strengthening, and provision of knowledge products. With the operationalization of AMA, the quest for local production of vaccines as part of the health sovereignty agenda, significant changes in the financial environment with an increasing tendency of traditional donors consolidating their funding envelops, direct competition amongst African Union organizations and WHO due to overlapping mandates, and the need for clear value addition, AVAREF is transforming into a WHO-AFRO Program (as opposed to a Secretariat for AVAREF) which will be focused on an ecosystem and life cycle approach from R&D to safe use of vaccines and vaccines. The Vaccine Research and Innovation Unit (VRIU) is responsible for developing a framework for end-to-end local production of vaccines ranging from vaccine research in the region including establishing research prioritization, a thriving research and development, regulatory and ethics oversight for clinical trials. Vaccine manufacturing, safety monitoring, and risk management. This end-to-end system requires an ecosystem and life cycle approach. The AVAREF program, which is the basis for this ecosystem approach, will require efforts of professionals who are competent, motivated, skilled with the right competencies, expertise, and experience to facilitate the delivery of results. The ability to attract and retain sustainable funds will require delivery of results from ongoing funded initiatives. It is for this reason that the AVAREF Program is seeking a Consultant Technical Officer Research and Development, Clinical Trials, Ethics, Regulatory safety, and Pharmacovigilance to support program development and delivery results.

2. Deliverables

The Consultant Research and Development, Clinical Trials, Ethics, Regulatory Safety, and Pharmacovigilance will work closely with the Coordinator, AVAREF Program, the staff within the Program, member states, and interested and affected stakeholders to support the development of the R&D, clinical research, ethics, and safety component of a strategy which leverages the AVAREF network to ultimately support increasing access to innovative, affordable, safe, and effective vaccines and medicines of assured quality in the African Region.

Support for AVAREF Secretariat
Comparative assessment of regulatory frameworks for ethics leveraging work done with TRACE project to 12-member states in the reliance network as well as others within the region.
Analysis of results to generate regional recommendations for a harmonized ethics framework to facilitate quality and timely reviews.
Publication on comparative legislative analysis of regulatory and ethics frameworks for clinical trials for reliance countries.

Development of Strategy for Research and Development for Vaccines in the African Region
Support the development of a regional R&D Strategy in collaboration with R&D Team in HQ and research teams.

Development of Networks along the innovation life cycle by leveraging the AVAREF 16-member clinical trial pilot
Support the AVAREF Secretariat in the establishment of networks and platforms along the innovation life cycle, specifically for R&D, clinical research and sites, ethics, and local manufacturers towards Strengthening an Ecosystem Approach to End-to-End Local production of Medicines, Vaccines, and Other Health Technologies in Africa.

Leading the preparation (and publication) of journal articles for VRIU

Supporting Development of Knowledge and Advocacy products

Specifically, the Consultant will perform the following tasks:
• Support AVAREF Secretariat in performing comparative assessment of legal frameworks and their implementation in the 16 pilot countries. This analysis will be used in generating recommendations or best practices amongst the member states for ethical oversight of clinical trials that is at par with international standards.
• Support the development of the R&D strategy for Africa.
• Establish the networks within the ecosystem to facilitate ecosystem and life cycle approach to capacity building and strengthening.
• Prepare scientific articles for publication based on work products from the AVAREF Program.
• Support the development of additional work products to support advocacy and fundraising such as the development of grant proposals.

Expected Outputs
• Report on Comparative analysis of ethical frameworks including analysis, options, and recommendations for the reliance network and others in the region.
• R & D Strategy document for vaccine research for the African region.
• Established networks for NEC, Clinical Researchers/Sites, Manufacturers associated with the reliance network.
• Manuscripts for publication based on output of the AVAREF program.
• Grant proposals and other advocacy documents.

3. Qualifications, experience, skills and languages

Educational Qualifications

Essential: Advanced university degree in Medicine with specialization in public health, pharmacoepidemiology, biomedical sciences, or pharmaceutical science.

Desirable: Post graduate degree in health related or life science, project management, pharmacology, pharmacoepidemiology, and work within National Regulatory Agencies.
Experience

Essential
Minimum of 7 years of combined experience in regulatory agency, clinical research, laboratory environment, or research institution.
Experience in regulatory affairs, project management or pharmacovigilance within the national regulatory authorities, pharmaceutical industry, university, or within a science-based organization.
Experience working with regulatory and ethics capacity building.
Confirmed experience of working in collaboration with a wide range of stakeholders.

Desirable
Experience working in Africa (or low- and middle-income countries) as well as in advanced economies.

Skills/Knowledge
Strong leadership, communication, decision making, and problem-solving skills.
Skills required in working internationally, including Africa and in developed economies.
Proven skills in results communication.
Ability to work as a team under tight deadlines and work in a multicultural environment.
Publication on comparative legislative analysis of regulatory and ethics frameworks for clinical trials for reliance countries.

Other Skills
Excellent knowledge of data collection tools, Statistical packages, Communication packages and Microsoft application (e.g. Excel, Word, Power Point, etc.), xml.
Knowledge of project management software.
Languages required
Essential: Expert knowledge of English or French.
Desirable: Intermediate knowledge the other language or any other UN official language.

4. Technical Supervision

The Incumbent will be supervised by the Technical Officer, Implementation Research Portfolio Coordinator, AVAREF Secretariat (WHO-AFRO)

5. Location

Off-site (Home-based)

7. Remuneration and budget (travel costs excluded)

Band level B - USD 7,000 - 9,980 per month

8. Expected duration of contract

An initial duration of 6 months with the possibility of extension

9. 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 .
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• 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 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 final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever 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 in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html