Location: SNNPR in regional and zonal level
Duration: 12 months (1st July 2022 to 30 June 2023) with possibility of extension based on the satisfactory and above performance
No.of consultant: 04
Start Date: July 2022
Reporting to: Product Safety Directorate, EFDA and UNICEF
Project and activity codes: 001/002

Background:

World Health Organization declared the COVID-19 outbreak a public health emergency of international concern, WHO's highest level of urgency. On 11 March, WHO made the assessment that COVID-19 could be characterized as a pandemic. On March 13, 2020 the first confirmed COVID-19 case was declared by the Ministry of Health of Ethiopia.
The Ethiopian Food and Drug Authority (EFDA) is the National Regulatory Authority responsible to protect and promote the public health by ensuring that medicinal products (pharmaceuticals, biologicals including vaccines, blood products and other biological) are of acceptable quality, safety and efficacy, are manufactured, distributed and uses in ways which ensure their quality until they reach the patient/consumer/, and their commercial promotion is accurate.
The Authority is also responsible for safety of food supply, cosmetics, Dietary supplements, safety, Quality and effectiveness of medical products and public health aspects of tobacco products. To carry out its responsibility of ensuring the Quality, safety, and effectiveness of EFDA regulated medical products; the Authority Organizes itself in different regulatory functions.
One of the Authority' s highest priorities is ensuring the quality, safety and effectiveness of Medicines, Biological products and vaccines in general and COVID-19 vaccines safety monitoring. AEFI surveillance system focuses on vaccine safety, and it utilizes tools such as guidelines and procedures geared to assure public health protection using vaccines with proven safety profile and ensure quality. The current system for monitoring drug safety (pham1acovigilance) is being coordinated by the National Regulatory Authority (NRA) under Product Safety Directorate.
Therefore, the technical assistance for COVID-19 Vaccine safety monitoring and Adverse Event Following Immunization (AEFI) Surveillance will responsible and cover the various activities and deliverables within the introduction of COVID-19 vaccine safety monitoring, in the ongoing and routine vaccinovigilance activities, and to support the everyday management and implementation of robust vaccine pharmacovigilance system and strengthen functional AEFI surveillance system in the assigned regions and zones.

Purpose of the position:

To provide technical assistance on COVID-19 vaccine safety monitoring, in the ongoing and routine vaccinovigilance activities, and to support the everyday management and implementation of robust vaccine pharmacovigilance system and strengthen functional AEFI surveillance system in the assigned regions and zones.

Specific Tasks:

• Collect AEFI reports and other COVID-19 vaccine safety reports from consumers and HCPs
• Coordinate and support the catchment health facilities HCPs for reporting of AEFIs and other covid-19 vaccine safety related events.
• Coordinate advocacy, training on AEFI surveillance system to healthcare providers and immunization/health stakeholders.
• Provide training on AEFI and COVID-19 safety issues for HCPs.
• Coordinate the investigation process of serious Adverse Events Following Immunization (AEFI) and other eligible cases for investigation.
• Participate in AEFI investigation with the AEFI team of regional EFDA.
• Prepare AEFI report.
• Ensure the availability of AEFI tools in all health facilities and vaccination site.
• Create communication platform with various vaccine pharmacovigilance stakeholders.
• Create and implement proper communication channels linking vaccinators, regional health bureau, EFDA and Ministry of Health for receiving AEFI repo1is from health facilities to regional/zonal level.
• Maintain Adverse Event Following Immunization (AEFI) reports and other record and database.
• Conduct regular supervision and follow up of immunization sites.
• Participate in active vaccine pharmacovigilance surveillance activities identified by the authority.
• Prepare and disseminate vaccine pharmacovigilance communication tools such as regular newsletters, bulletins, breachers, letter to healthcare professionals, media communication.
• Coordinate implementation of the regional/zonal pharmacovigilance road map.
• Participate in the development activities of vaccine pharmacovigilance directives, guidelines, SOPs, and tools.
• Coordinate the identification, assessment and management of any risks associated with vaccines.
• Conduct other activities order by the regional pharmacovigilance center.

Reporting:

The Technical Assistance for COVID-19 Vaccine safety monitoring and Adverse Event Following immunization (AEFI) Surveillance will be assigned in regional/zonal EFDA office and will be reporting to the pharmacovigilance and clinical trial team under the product safety directorate of regional EFDA. In addition, the technical assistance should have smooth technical communication and relation with RHB and regional/zonal EPI program.

Expected Deliverables and Time frame:

Deliverables Deadline

• In-depth desk review of the phannacovigilance system conducted and preliminary situation analysis report submitted. 
  • Initial and quarterly
• Submission of improvement plan for the phannacovigilance system.
  • Initial and bi-annual
• Meeting documentation on consultation and validation meetings of the improvement plan with the main private and public stakeholders involved. 
  • Quarterly
• Workshops conducted with key stakeholders to adapt the AESI guidelines to the country context 
  • Initial and bi-annual
• Training modules developed for personnel involved in the pharmacovigilance system at the central and regional level 
  • Bi-annual
• Regional level ToT conducted on pharmacovigilance and vaccine safety surveillance. 
  • Quarterly
• Surveillance tools and training module adapted to include immunization safety surveillance in pregnant and lactating women who have received COVID19 vaccines, as well as their respective children
  • Initial and bi-annual
• Budget estimate developed for the five-year pharmacovigilance improvement plan. 
  • Bi-annual
• Technical guideline reviewed for carrying out vaccine efficacy studies against COVID19 and rep01i submitted. 
  • Bi-annual
• Submission of regular monitoring and evaluation reports 
  • Quarterly
• Prepared and shared the technical reporting of the mid-term project
  • Bi-annual
• Submission of the final report 
  • Annual

Payment Modality & schedule:

The fees for this contract shall paid on monthly basis based on the submission of monthly reports against the deliverables indicated above.