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

| Job Description - Consultant - Research and development, clinical trials, ethics, regulatory safety, and pharmacovigilance (AVAREF program) (2604141) Consultant - Research and development, clinical trials, ethics, regulatory safety, and pharmacovigilance (AVAREF program) -(2604141)Contractual Arrangement:External consultantContract Duration (Years, Months, Days):6 months## Job Posting:Sep 24, 2026, 1:22:56 PM## Closing Date:Oct 8, 2026, 5:59:00 PM## Primary Location:Congo-Brazzaville## Organization:AF/DPC Health Promotion, Disease Prevention and Control## Schedule:Full-timeIMPORTANT NOTICE:Please note that the deadline for receipt of applications indicated above reflects your personal device's system settings...## 1.    Background and JustificationAVAREF, 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.    DeliverablesThe 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 SecretariatComparative 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 RegionSupport 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 pilotSupport 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 VRIUSupporting Development of Knowledge and Advocacy productsSpecifically, 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