Scientist (Vaccines Prequalification) - Geneve, Schweiz - OMS

Beschreibung

Critères de l'offre


L'entreprise:


OMS

OMS
Description du poste


OBJECTIVES OF THE PROGRAMME

The Regulation and Prequalification Department (RPQ) 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.

RPQ works within the Access to Medicines and Health Products Division (MHP) division departments in the wider framework of Universal Health Coverage and category 4 of the General 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.

To ensure access to high quality vaccines for National Immunization Programmes through the timely and adequate establishment of norms and standards, the prequalification of vaccines for purchase by UN agencies,strengthening national regulatory capacity both in the short and long-term and the assessment of vaccine safety issues at global level.

DESCRIPTION OF DUTIES
Under the general supervision of the Team Lead, Vaccines & Immunization Devices Assessment in PQT the incumbent is responsible for:

• Following up with manufacturers of recently prequalified combinations and novel vaccines on the timely submission of post-prequalification clinical study commitments, and to coordinate the review of such data.
• Providing consolidated reports of the reviews with an opinion on the acceptability, or not, of the available information and responsibility for coordinating the review of any complementary information ora dditional studies that may be required.
• Creating and updating documents providing additional guidance to WHO clinical reviewers on the scope of the review and specific aspects that need to be considered to assess the suitability of the vaccine/sfor the UN agencies target populations, with a view at harmonizing the review by different assessors.
• Assisting in developing a procedure/setting criteria for confirming Good Clinical Practice (GCP) (i.e inspections).
• Developing specific guidance based on the WHO Clinical Guidelines on potential protocol design for clinical evaluation of combination vaccines, rotavirus, HPV and other novel vaccines and/or novel delivery systems.
• Giving advice to manufacturers approaching WHO to request orientation on the suitability of the proposed protocols for trials.
• Contributing to assessment through feed back to the Vaccine Regulation staff, on the ability of the responsible National Regulatory Authorities to oversee the conduct of clinicaltrials and to evaluate clinical trial data.
• Feeding the vaccine quality data base with the relevant clinical information for each vaccine that is prequalified.
• Participating in evaluation and responding to incidents of vaccine related complaints. Providing 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 participates in providing immediate advice to WHO, UNICEF Supply, other UN agencies, the vaccine producers, regulatory authorities and immunization programme officials.

Assisting in developing systems for investigation and analysis of such problems, formulating appropriate responses and preparing information documents on their resolution.

• Providing expert technical advice on the clinical performance of vaccines with the focus on pre-qualified vaccines (efficacy and safety).
• Identifying training needs and contributing to the development of appropriate training curricula to be provided through GTN or other mechanisms.
• Contributing to the update of the Procedure for assessing the acceptability, in principle, of vaccines for purchase through UN agencies.
• Undertaking other duties as assigned by the Team Lead, PQT Vaccines & Immunization Devices Assessment and the PQT Unit Head.

REQUIRED QUALIFICATIONS
Education


Essential:

• University degree in Medical Biology, Microbiology or related science.
• Postgraduate degree in Epidemiology with focus on infectious diseases.

Desirable:

Training in biostatistics.

Experience


Essential:

• At least 7 years of experience in the field of infectious diseases, 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
• At least 5 years respective experience at the national level.

Desirable:

• Experience at the international level is a distinct asset.
• Familiarity with the WHO prequalification procedure, with WHO activit