Consultants - Safety Surveillance of new vaccines

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Application deadline 2 years ago: Thursday 9 Sep 2021 at 21:59 UTC

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  1. Purpose of the consultancy

The purpose of this consultancy is to provide technical support to the Ministry of Health and the WHO country office to strengthen safety monitoring Programme of COVID19 vaccines (and other new vaccines) and revitalize the national regulatory authority in Djibouti.

<pre style="text-align:justify">
<span style="font-size:10pt"><span style="background:white"><span style="font-family:"Courier New""><span style="font-size:11.0pt"><span style="font-family:"Calibri",sans-serif"><span style="color:#002060">The general objective of the consultation is to strengthen the skills of specialized health personnel at the central and subnational levels of the country, in pharmacovigilance in general and in vaccine vigilance in particular, with a focus on the COVID 19 vaccine, in order to enhance more visibility and responsiveness to the occurrence of any post-vaccine adverse events that may occur, during the COVID19 response period. </span></span></span></span></span></span>
  1. Background

The COVID 19 pandemic has upset all codes of conduct and has led health systems taken by surprise to put in place health crisis management plans.

After the WHO declarations of the SARS-COV2 disease as a Public Health Emergency of International Concern on 30 January 2020, then as a pandemic on 11 March 2021, Djibouti notified the very first case on 18 March 2020. Two waves were observed respectively in 2020 and 2021.

The national commitment was marked by the creation of a national commission responsible for coordinating the response to COVID19, and subsequently, the creation of a national commission for deployment and vaccination, which facilitated coordination and development of the national deployment and vaccination plan, through its strategic sub-committees, communication, and field operations.

Djibouti, as one of the countries eligible for GAVI, regularly followed all the necessary steps for technical assistance, from the request to the supply of vaccines, to the deployment and the vaccination operation in the approved vaccination site.

With the huge support of COVAX mechanism and bilateral agreements: several types of vaccines have been made available throughout the country, strengthening, and complementing the implementation of other pillars of the response strategy to the COVID19 pandemic.

These vaccines, introduced in April 2021, made it possible to strengthen the preventive pillar of vaccination, and to contain the second epidemic wave recorded in 2021, with the recurring peaks observed in March-April.

Through the combined efforts of the national side and international solidarity, reflected by the constant commitment of technical and financial multilateral and bilateral partners, along with the COVAX facility, the preparation and response to this pandemic has been organized around the National Deployment and vaccination plan.

The essentially dynamic nature of this disease, and the appearance of many variants, and new vulnerable targets, justify a regular update of the entire strategy, and appropriate risk communication aimed at strengthening the commitment of community and generate demand for vaccines. In addition, the unprecedented feat achieved by the global scientific community has been the development of numerous high quality and effective vaccines in less than a year. Thus, several types of vaccines have been developed, some using new technological platforms, and other vaccines having received an authorization for emergency use listing by the WHO, and / or the national authorities. The deployment of these vaccines, which have received EUL or are being examined by the WHO, have made it possible to considerably reduce the severe forms of disease, which would have required hospitalizations with or without resuscitation, and above all have contributed to the reduction in the COVID19-related mortality.

The global vaccination campaign phase saw the appearance of certain AEFI and AESI that were not described during the advanced clinical phases, which had an impact on the demand for vaccines and justifying an increased effort to monitor vaccine safety, in order to reassure the population.

Based on these experiences and in accordance with the global vaccine safety guide, Djibouti is committed in the post-introduction phase of COVID19 vaccines to strengthen vaccine vigilance, through AEFI and AESI surveillance, and to revitalize the national regulatory authority, as well as the various AEFI/AESI and causality assessment committees.

This intensive surveillance in an emergency context will essentially aim to ensure the safety of people and organize communication for better demand and uptake.

  1. Planned timelines:

Due to the COVID 19 pandemic, and in harmony with travel policies, the mission will take place as follows: face to face and or remotely, or in hybrid mode,

The duration of the consultation is for 6 months or less.

4. Work to be performed

Output 1: Support for the implementation of the vaccine security component of the National Deployment and Vaccination Plan against COVID19:

  • Deliverable 1.1: Strengthen the passive and active surveillance system of AEFI and AESI at the national and subnational levels.
  • Deliverable 1.2: Facilitate the participation to the national and International reporting network, to accelerate the definition of the safety profile of new COVID 19 vaccines through reporting of AEFI and AESI in the UPPSALA international surveillance center and the WHO surveillance system.
  • Deliverable 1.3: Provide technical expertise for carrying out vaccine efficacy studies against COVID19
  • Deliverable 1.4: Support the country to conduct post-introduction evaluations of new vaccines (COVID19, nOPV2, MR, HPV, etc.)
  • Deliverable 1.4: Adapt surveillance tools and training module to include immunization safety surveillance in pregnant and lactating women who have received COVID19 vaccines, as well as their respective children.

Output 2: Provide support for the revitalization of the vaccine safety Committee (AEFI causality assessment committee) and improve coordination with other established committees.

  • Deliverable 2.1: Contribute to the structural and functional strengthening of the national regulatory authority, AEFI/AESI committee, causality assessment committee,

  • Deliverable 2.2: Facilitate study tours of the Djibouti team to countries for learning from the experience and expertise of the vigilance regulatory function, from a well-functioning national regulatory authority or stringent regulatory authority.

Output 3****: Ensure an analysis of the pharmacovigilance situation in Djibouti.

  • Deliverable 3.1: To Conduct an in-depth desk review of the pharmacovigilance system in Djibouti.

  • Deliverable 3.2: Ensure the collection and desk review of all existing documents essential to the mission.

  • Deliverable 3.3: Provide remote or face-to-face, individual and group consultations with national actors involved in the pharmacovigilance system
  • Deliverable 3.4: Identify weaknesses and gaps to be filled.
  • Deliverable 3.5: Produce a preliminary analysis report of the situation analysis.

Output 4****: Develop a five-year plan to improve the pharmacovigilance system in Djibouti.

  • Deliverable 4.1: Produce a draft plan to improve the pharmacovigilance system.
  • Deliverable 4.2: Organize and lead consultation and validation meetings of the improvement plan with the main private and public stakeholders involved.
  • Deliverable 4.3: Provide a budget estimate for the five-year pharmacovigilance improvement plan.

Output 5: Support the implementation of the pharmacovigilance system improvement plan:

  • Deliverable 5.1: Develop training modules to be used for the training of personnel involved in the pharmacovigilance system at the central and regional level.
  • Deliverable 5.2: Provide training for trainers on pharmacovigilance and vaccine safety surveillance.
  • Deliverable 5.3: Provide technical expertise for the structural and functional strengthening of a pharmacovigilance center.
  • Deliverable 5.4: Contribute to the establishment of a contextualized pharmacovigilance guide in Djibouti along with vaccine safety tools.
  • Deliverable 5.5: Provide coaching to field teams and various committees, based on interviews and discussions, formative supervision, interactive weekly animation.

Output 6: Produce the various technical reports:

  • Deliverable 6.1: Prepare and present regular monitoring and evaluation reports,
  • Deliverable 6.2: Prepare and share the technical report of the mid-term mission
  • Deliverable 6.3: Produce the general report at the end of the mission

5. Technical Supervision

The selected Consultant will work under the supervision of:

Responsible Officer:

Dr KEMENANG Edie-Alain, Programme officer

*, WHO-Djibouti*

Manager:

Dr Reinhilde VAN DE WEERDT

WHO Representative Djibouti

Djibouti

  1. Specific requirement:

Qualification required

  • Essential: Advanced university degree in Pharmacology, clinical pharmacy, Medicine.

  • Desirable: Advanced studies in toxicology and vaccine development, post graduate degree in public health, epidemiology or equivalent.

Experience required:

    • Essential: At least 10 years of proven experience in the field of pharmacovigilance, vaccine safety or related field, and capacity building.
    • Desirable: Experience of work with UN system, WHO Collaborating Center for Pharmacovigilance, national regulatory authority, international institutions or iNGOs supporting vaccine safety and pharmacovigilance surveillance.
  • Skills / Technical skills and knowledge:

    • Ability to collaborate or manage a diverse group of stakeholders from multi-cultural backgrounds
    • Excellent knowledge of the coaching concept necessary to build a robust pharmacovigilance and vaccinovigilance system.
    • Demonstrated strong communication skill.
    • Excellent written and spoken French,
    • Proficiency in Microsoft Office software package: (Word, Excel, PowerPoint),
    • Ability to work in team with flexibility.
    • Demonstrated similar results in strengthening pharmacovigilance and / or vaccine vigilance in other settings.
    • Demonstrated competence through long experience in the quality, safety and efficacy of vaccines.
    • Demonstrated ability to work effectively with MoH and health staff as a team at national and subnational levels, virtually or face to face.
  • Language requirements:

    • Excellent knowledge of French (Spoken and written),
    • knowledge of Arabic will be an asset
  1. Travel

The consultant is expected to travel.

All travel arrangements will be made by WHO – WHO will not be responsible for tickets purchased by the Consultant without the express, prior authorization of WHO. While on mission under the terms of this consultancy, the Consultant will receive subsistence allowance.

Visas requirements: it is the consultant’s responsibility to fulfil visa requirements and ask for visa support letter(s) if needed

ADDITIONAL INFORMATION

  • This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
  • Only candidates under serious consideration will be contacted.
  • A written test may be used as a form of screening.
  • If your candidature is retained for 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.
  • For information on WHO's operations please visit: http://www.who.int.
  • WHO is committed to workforce diversity.
  • WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
  • Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
  • WHO's workforce adheres to the WHO Values Charter and is committed to put the WHO Values into practice - https://www.who.int/about/who-we-are/our-values
  • Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
  • WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
Added 2 years ago - Updated 2 years ago - Source: who.int