Consultant Technical Officer Research and Development, Clinical Trials, Ethics, Regulatory Safety, and Pharmacovigilance

Job Posting Organization:
AVAREF, which stands for AdVancing ClinicAl TRials Excellence in AFrica, is a network established by the World Health Organization (WHO) 20 years ago. Its primary mission is to build capacity among National Regulatory Authorities (NRAs) and National Ethics Committees (NECs). The organization has made significant strides in enhancing vaccine research and development through clinical trials, achieving major milestones in the clinical trial ecosystem over the past two decades. The AVAREF Secretariat operates within the Vaccine Research and Innovation Unit (VRIU) of the Vaccine Preventable Diseases (VPD) Program, focusing on a wide range of activities including capacity building initiatives, technical assistance to member states, and coordination with partners and stakeholders. AVAREF has been instrumental in facilitating research and development through clinical trials, supporting the registration of emergency use vaccines, and contributing to the training of reviewers within NRAs. The organization is currently implementing its 2024-26 Strategic Operational and Action Plan, which emphasizes partnerships, expert support, and a life cycle approach to vaccine development.

Job Overview:
The Consultant Technical Officer will play a crucial role in supporting the development of research and development (R&D), clinical research, ethics, and safety components of a strategy that leverages the AVAREF network. The primary goal is to increase access to innovative, affordable, safe, and effective vaccines and medicines of assured quality in the African Region. The consultant will work closely with the Coordinator of the AVAREF Program, staff, member states, and stakeholders to achieve these objectives. This position requires a deep understanding of the clinical trial landscape, regulatory frameworks, and ethical considerations in vaccine research. The consultant will also be responsible for developing strategies that align with AVAREF's mission and operational goals, ensuring that the organization remains a leader in the field of vaccine research and development.

Duties and Responsibilities:
The Consultant will be responsible for a variety of tasks, including conducting comparative assessments of regulatory frameworks for ethics in collaboration with the TRACE project, analyzing results to generate regional recommendations for a harmonized ethics framework, and publishing findings on legislative analyses of regulatory and ethics frameworks for clinical trials. Additionally, the consultant will support the development of a regional R&D strategy, establish networks along the innovation life cycle, and lead the preparation of journal articles for publication. The consultant will also assist in developing knowledge and advocacy products, including grant proposals, to support AVAREF's initiatives. Expected outputs include reports on comparative analyses, R&D strategy documents, established networks for clinical researchers, and manuscripts for publication.

Required Qualifications:
Candidates must possess an advanced university degree in Medicine with a specialization in public health, pharmacoepidemiology, biomedical sciences, or pharmaceutical science. A postgraduate degree in health-related or life sciences, project management, or pharmacology is desirable. Essential qualifications include a minimum of 7 years of combined experience in regulatory agencies, clinical research, or laboratory environments, with a strong background in regulatory affairs, project management, or pharmacovigilance. Experience working with regulatory and ethics capacity building is also essential, along with confirmed collaboration with a wide range of stakeholders. Desirable qualifications include experience working in Africa or low- and middle-income countries, as well as in advanced economies.

Educational Background:
The educational background required for this position includes an advanced university degree in Medicine, with a specialization in areas such as public health, pharmacoepidemiology, biomedical sciences, or pharmaceutical science. A postgraduate degree in health-related or life sciences, project management, or pharmacology is considered desirable, particularly for candidates who have experience working within National Regulatory Agencies.

Experience:
The position requires a minimum of 7 years of combined experience in relevant fields such as regulatory agencies, clinical research, laboratory environments, or research institutions. Candidates should have experience in regulatory affairs, project management, or pharmacovigilance, particularly within national regulatory authorities, the pharmaceutical industry, or science-based organizations. Experience in regulatory and ethics capacity building is essential, as is the ability to work collaboratively with a diverse range of stakeholders. Desirable experience includes working in Africa or low- and middle-income countries, as well as in advanced economies.

Languages:
Candidates must have expert knowledge of either English or French, which are essential for this position. Intermediate knowledge of the other language or any other UN official language is desirable, as it may enhance communication and collaboration within the international context of the role.

Additional Notes:
The position is off-site (home-based) and offers a remuneration band level of USD 7,000 - 9,980 per month. The initial duration of the contract is 6 months, with the possibility of extension. This vacancy notice may also be used to identify candidates for other similar consultancies at the same level. Only candidates under serious consideration will be contacted, and a written test may be used as a form of screening. Candidates selected for an interview will need to provide scanned copies of their required educational qualifications in advance. WHO emphasizes workforce diversity and encourages applications from women and nationals of non-represented Member States. The organization adheres to the highest ethical and professional standards and has a zero-tolerance policy towards sexual exploitation and abuse, sexual harassment, and other forms of abusive conduct.