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.
Coordinates the implementation of the antivenom risk-benefit assessment project, including:
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Day-to-day management of the project activities according to the final work plan, and in accordance with WHO policies;
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Conduct of the dossier review by an independent scientific panel;
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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;
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The assessment of compliance with WHO Good Manufacturing Practice (GMP) of manufacturing sites;
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Scientific analysis of data generated during risk-benefit assessments and produce technical reports and assessments to support evidence-based decision-making processes;
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Donor reporting according to agreed timelines between WHO and the donor;
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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.
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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.
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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.
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.
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.
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).
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Teamwork
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Respecting and promoting individual and cultural differences
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Communication
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Producing results
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Moving forward in a changing environment
Essential: Expert knowledge of English.
Desirable: Expert knowledge of French. Intermediate knowledge of UN language.
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.
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This vacancy notice may be used to fill other similar positions at the same grade level
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Only candidates under serious consideration will be contacted.
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A written test and/or an asynchronous video assessment may be used as a form of screening.
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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.
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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.
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Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.
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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.
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Staff members in other duty stations are encouraged to apply.
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WHO is committed to creating a diverse and inclusive environment of mutual respect. WHO recruits and employs staff regardless of disability status, sex, gender identity, sexual orientation, language, race, marital status, religious, cultural, ethnic and socio-economic backgrounds, or any other personal characteristics.
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WHO is committed to achieving gender parity and geographical diversity in its staff. Women, persons with disabilities, and nationals of unrepresented and underrepresented Member States (https://www.who.int/careers/diversity-equity-and-inclusion) are strongly encouraged to apply.
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Persons with disabilities may request reasonable accommodations (modifications or adjustments to the application or recruitment process) to support their participation in the application and recruitment process. Please send an email to [email protected] with your full name, the vacancy number you are applying for, and specific details of the accommodation needed in your request.
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An impeccable record for integrity and professional ethical standards is essential. WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
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WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
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Mobility is a condition of international professional employment with WHO and an underlying premise of the international civil service. Candidates appointed to a fixed-term position in the International Professional category (Grades P1-D2) are eligible for Geographical Mobility and may be assigned to any activity or duty station of the Organization throughout the world.
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WHO also offers wide range of benefits to staff, including parental leave and attractive flexible work arrangements to help promote a healthy work-life balance and to allow all staff members to express and develop their talents fully.
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The statutory retirement age for staff appointments is 65 years. For external applicants, only those who are expected to complete the term of appointment will normally be considered.
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Please note that WHO's contracts are conditional on members of the workforce confirming that they are vaccinated as required by WHO before undertaking a WHO assignment, except where a medical condition does not allow such vaccination, as certified by the WHO Staff Health and Wellbeing Services (SHW). The successful candidate will be asked to provide relevant evidence related to this condition. A copy of the updated vaccination card must be shared with WHO medical service in the medical clearance process. Please note that certain countries require proof of specific vaccinations for entry or exit. For example, official proof /certification of yellow fever vaccination is required to enter many countries. Country-specific vaccine recommendations can be found on the WHO international travel and Staff Health and Wellbeing website. For vaccination-related queries please directly contact SHW directly at [email protected].
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WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
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For information on WHO's operations please visit: http://www.who.int.
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The appointment type offered to the selected candidate will be determined at the time of the offer: current staff members will keep their appointment type; other candidates, unless joining through interagency transfer, will be offered a temporary appointment.
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Staff members separated due to the 2025 Prioritization and Realignment Process will receive special consideration according to the applicable regulatory framework
