: Regional Vaccine Safety Monitoring and Adverse Event Following Immunization (AEFI) Surveillance System Technical Assistance- Oromia

ABH Partners PLC

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

Salary Not Available



Career Level
Senior Level
Type of corporation
Company size

Location: Oromia in regional and zonal level

Duration: 12 months (1st July 2022 to 30 June 2023) with the possibility of extension based on the satisfactory and above performance

No.of consultant: 05

Start Date: July 2022

Reporting to: Product Safety Directorate, EFDA and UNICEF

Project and activity codes: 001/002


World Health Organization declared the COVID-19 outbreak a public health emergency of international concern, WHO's the highest level of urgency.On 11 March, WHO made theassessment that COVID-19 could be characterized as a pandemic. On March13, 2020 the first confirmedCOVID-19 case was declared by the Ministryof 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 the 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 profiles and ensure quality. The current system for monitoring drug safety (pham1acovigilance) is being coordinated by the National Regulatory Authority (NRA) under the 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: 

Twomen whoystem in the assigned regions and zones.


Specific Tasks:


  • Collect AEFI reports and other COVID-19vaccine safety reportsfrom consumers and HCPs
  • Coordinate and supportthe catchment healthfacilities HCPs for reporting of AEFIs and other covid-19 vaccine safety related events.
  • Coordinate advocacy, trainingon 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 seriousAdverse 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 a 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 repo1isfrom health facilities to regional/zonal level.
  • Maintain Adverse Event Following Immunization (AEFI) reports and other records and databases.
  • 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, letters to healthcare professionals, and 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.




The Technical Assistance for COVID-19 Vaccinesafety monitoring and Adverse Event Following Immunization (AEFI) Surveillance will be assigned in the 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:




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 mainwere  private and public 

stakeholders involved.


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 the 

centraland regional level


Regional level ToT conducted 

on pharmacovigilance and 

vaccinesafety surveillance.


Surveillance tools and training

 module adapted to include immunization

safety surveillance in pregnant

 and lactating womenwho 

have received COVID19 vaccines

evaluation reports, as well as their 

respective children

Initial and bi-annual

Budget estimate developed 

for the five-year pharmacovigilance 

vaccine efficacy and shared improvement plan.


Technical guidelines final report reviewed for carrying out vaccineefficacy studies against COVID19 and rep01i submitted.


Submission of regular monitoring and evaluationreports


Prepared andshared the technical reporting of the mid-term project


Submission of the finalreport


Payment Modality & schedule:

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

Expected educational background and experience:

  • University Degree in pharmacy, medicine, nurse, or health officer with a minimum of 3 to 5 years experience who are interested to work at regional and city administration levels.
  • Having basic/advanced Adverse Events Following Immunization (AEFI) surveillance or Vaccine Pharmacovigilance/General Pharmacovigilance training in the last two years is a must.
  • Work experience in regulatory areas or Pharmacovigilance is an advantage.

Core competencies: 

  • Ability to analyze good vaccine pharmacovigilance or AEFI surveillance requirements
  • Strong analytical skills
  • Promotes knowledge sharing and learning culture in the office
  • In-depth knowledge and ability to advocate and provide pharmacovigilance activities
  • Actively works towards continuing personal learning and development in one or more practice areas,
  • Focuses on impact and result for the client and responds positively to feedback
  • Demonstrates openness to change and ability to manage complexities.
  • Ability to work in multicultural and stressful situation.
  • Ability to work in team and independently.
  • Excellent language skill (spoken and written) in English.
  • Excellent skills in basic Microsoft office.


  • The consultants will be based at city/regional/zonal EFDA level
  • The consultant will not be provided lodging and/ormeals
  • The consultai1t will use his/her own materials, i.e., computer/laptop, phone etc.
  • For the duty travel, the consultant will be provided a rented car by HR firm and DSA as per the guideline.
  • The consultant will bepaid monthly by ABH Partners Plc upon completion of deliverables as indicated on this TOR and approved by the supervisor


Policy both parties should be aware of:

  • ABH Partners Plc will manage all the administrative issues and aspects based on HR policies and procedures.
  • All remuneration must be within the contract agreement through the ABH Partners Plc.
  • No contract may commence unless the contract is signed by both Partners Plc and the consultant.
  • Travel will be facilitated and managed by the ABH Partners PLc in agreement with UNICEF.
  • Consultants will not have supervisory responsibilities or authority on the UNICEF budget.