Technical Officer (Regulation and Prequalification)

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OBJECTIVES OF THE PROGRAMME The objectives of the Department of Regulation and Prequalification (RPQ) are to ensure the quality, safety and efficacy of medicines and health products globally. The immediate strategic objective and priorities is to achieve greater country impact through building capacity of Regulatory systems in LMIC, establishment of reliance mechanism among National Regulatory Authorities, and streamlining prequalification processes of quality-assured, safe and effective medicines and health products, thereby contributing to global health and sustainable development. RPQ department closely works with the Health Product Standards and Access (HPS) department in line with the WHO Road map for access to safe, effective and quality-assured health products and technologies 2025-2030, and in collaboration with the wider framework of health systems-oriented programmes and disease-oriented programmes to contribute the 14th GPW and Sustainable Development Goals.

DESCRIPTION OF DUTIES

Coordinates the implementation of the antivenom risk-benefit assessment project, including:

• Day-to-day management of the project activities according to the final work plan, and in accordance with WHO policies;
• Conduct of the dossier review by an independent scientific panel;
• Coordination of the establishment of a Technical Services Agreement with the external laboratory. The physicochemical, compositional, antivenomic and specific activity testing of product samples by the external laboratory;
• The assessment of compliance with WHO Good Manufacturing Practice (GMP) of manufacturing sites;
• Scientific analysis of data generated during risk-benefit assessments and produce technical reports and assessments to support evidence-based decision-making processes;
• Donor reporting according to agreed timelines between WHO and the donor;
• Internal reporting as required by unit and departmental management. Ensure information acquired by WHO in the course of risk-benefit assessments of snakebite antivenoms and related therapeutics is curated in a central data repository in standardized form.
• Coordinate the partnership with Wellcome Trust, and other partners, in relation to WHO's antivenom risk-benefit assessment. This includes WHO responses to Wellcome Trust, and other partners, with respect to independent project reviews.
• Provide expert technical advice and support to the Department and the Unit Head on appropriate elements to be conveyed to Member States and WHO regional offices on the production, control and regulation of snake antivenom immunoglobulin products that will ensure achievement of measurable strategic goals for in-country snakebite programmes.

REQUIRED QUALIFICATIONS

Education

Essential: Advanced level university degree (Master's level or above) in Biology, Pharmacy, Chemistry, Biochemistry, Microbiology, Biomedical Sciences or related sciences from a recognized University.
Desirable: PhD in one of the fields identified above.

Experience

Essential: At least 7 years of experience in biological standardization and/or the development, production, control and quality assurance of vaccines and biologicals. Experience at both the national and international level.
Desirable: Experience in the development/manufacturing and quality control of snakebite antivenoms. Experience in regulation of snakebite antivenoms. Familiarity with WHO prequalification procedures and National Regulatory Authority assessment procedures.

Skills

Essential knowledge of procedures involved in the risk-based assessment of snake antivenoms. Demonstrated previous experience in the area of antivenom assessment and evaluation. Solid knowledge of regulatory requirements and variables related to biological products. Good understanding of issues related to good manufacturing practices (GMP).Knowledge of relevant quality management systems(QMS).

WHO Competencies

• Teamwork
• Respecting and promoting individual and cultural differences
• Communication
• Producing results
• Moving forward in a changing environment

Use of Language Skills

Essential: Expert knowledge of English.
Desirable: Expert knowledge of French. Intermediate knowledge of UN language.

REMUNERATION

WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 86,027 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 6502 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.

ADDITIONAL INFORMATION

• This vacancy notice may be used to fill other similar positions at the same grade level

• Only candidates under serious consideration will be contacted.

• A written test and/or an asynchronous video assessment may be used as a form of screening.

• In the event that your candidature is retained for an 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.

• According to article 101, paragraph 3, of the Charter of the United Nations, the paramount consideration in the employment of the staff is the necessity of securing the highest standards of efficiency, competence, and integrity. Due regard will be paid to the importance of recruiting the staff on as wide a geographical basis as possible.

• Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.

• The Director-General retains the discretion to not make any appointment to this vacancy, to make an appointment at a lower grade, or to make an appointment with a modified job description, including shortening the duration of the appointment.

• Staff members in other duty stations are encouraged to apply.

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