OBJECTIVES OF THE PROGRAMME
The mission of the Pacific Health Systems and Policy team is to support Member States in the Pacific to attain universal coverage of health services for better and equitable health outcomes. Health sector development acts as the foundation that both underpins and unifies public health efforts aimed at combating diseases and building healthy communities in an efficient and equitable manner, especially for high priority, excluded and underserved population groups. A strong health system foundation enables effectiveness of individual programmes and efficient use of shared system resources for all programmes. A strong health system also promotes appropriate integration of pro-poor, equity-enhancing, gender-responsive and human rights-based approaches.
WHO supports countries to strengthen national regulatory systems for pharmaceutical and medical products, to ensure access and availability of quality assured, safe, and effective medicines, vaccines and other medical products. At the request of the heads of health and PIC ministers of health, it aims to establish a subregional platform to support PICs to strengthen and perform regulations of medicines, vaccines and other pharmaceuticals in the PICs as well as the overall strengthening of pharmaceutical systems.
The incumbent will serve as the technical lead in implementing the functions of the subregional regulatory platform, particularly to support countries strengthen and perform licensing of establishments, registration and marketing authorization of medical products, quality assurance and post-marketing surveillance, pharmacovigilance and enforcing recalls and withdrawals. The incumbent shall work closely with the relevant government institutions and partners in countries.
DESCRIPTION OF DUTIES
- Serve as technical lead in supporting countries to perform and strengthen regulatory systems for medicines and medical products;
- In collaboration with technical units in the Regional Office for the Western Pacific and headquarters, develop guidelines for the performance and implementation of core regulatory functions in PICs, including licensing of establishments, registration or marketing authorization, quality assurance, postmarketing surveillance pharmacovigilance and recall and withdrawal of substandard, falsified and harmful products;
- In consultation with countries, facilitate the development of regulatory framework, institutions and systems and the overall implementation plan for medicines and medical technology regulations in PICs;
- Ensure operational delivery of planned activities related to the performance of regulatory functions for medicines and medical products across PICs in collaboration with counterparts from all levels of the organization;
- Provide technical leadership and support to complete pharmaceutical needs assessments in PICs;
- Coordinate support to PICs regarding the monitoring of drug safety, laboratory and other medical technologies, analyse results and outline recommendations for advocacy and policy interventions;
- Liaise with recognized drug regulatory authorities working in and with PICs to expedite regulatory assessment of essential medicines and technologies, and promote collaboration for capacity-strengthening and harmonization of regulations; and
- Carry out other technical and strategic tasks related to essential medicines and technology policies and systems strengthening as requested by the supervisors.
- Essential: University degree in any of the following: pharmacy, medicine, regulatory science. Postgraduate degree (at least master's degree) in pharmacy, medicine, regulatory science, biomedical science, law, public health or related fields from a university recognized in the International Association of Universities' Worldwide Database of Higher Education Institutions, Systems and Credentials (WHED).
- Desirable: Higher postgraduate training and qualification in pharmaceutical science, public health, health economics, pharmacoeconomics or related fields.
- Essential: At least seven years' work experience, at national and international levels, in medical products regulations, development of national essential medicines policies, medicines procurement including experience in the assessment of the pharmaceutical sector, national medicines regulatory systems, laws and regulations.
- Desirable: Experience in the development and implementation of regulatory strengthening, convergence and cooperation. Experience working in developing countries and with international organizations including the UN system would be an advantage.
- Extensive knowledge and experience in regulatory systems strengthening, regulatory science and pharmaceutical systems;
- Demonstrated knowledge and skills in national medicines policy, public health, health economics or other health-related disciplines;
- Formulation and enforcement of medicines policies, laws and regulations;
- Technical ability to conduct assessment of pharmaceutical sector, particularly medicines regulatory framework;
- Excellent communication and presentation skills with ability to write in a clear and concise manner and to give technical advice and guidance taking into consideration the views of multiple stakeholders and partners;
- Negotiation and representational skills which allow coming to a common understanding of complex and often controversial issues;
- Ability to work harmoniously as a member of a team, adapt to diverse educational and cultural backgrounds and maintain a high standard of professional and personal conduct.
Teamwork: Respecting and promoting individual and cultural differences
Producing results: Building and promoting partnerships across the organization and beyond
Use of Language Skills
- Essential: Expert knowledge of written and spoken English.
- Desirable: Intermediate knowledge of other UN language.