To provide technical assistance on COVID-19 vaccine safety monitoring, in the ongoing and routine vaccine vigilance activities, and to support the everyday management and implementation of a robust vaccine pharmacovigilance system and strengthen the functional AEFI surveillance system in the country.
Salary Not Available
Type of corporation
Location: Benishangul Gumuz 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: 01
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 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 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 androutine 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.
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, 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 vaccinatin site.
Createcommunicationpatform 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 recorded 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, 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 ordered 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 the regional/zonal EPI program.
Expected Deliverables and Time frame:An in-depth
In-depth desk review of the pharmacovigilance system conductedan 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 themain private and public stakeholders involved.
Workshops conducted with key stakeholders to adapt the AESI guidelines to the countrycontext
Initial and bi-annual
Training modules developed for personnel involved in the pharmacovigilance systemat 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, as well as their respective children
Initial and bi-annual
Budget estimate developed for the five-year pharmacovigilance improvement plan.
Technical guideline 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 contractshall paid on monthly basis based on the submission of monthly reports againstthe deliverables indicatedabove.
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.
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 notbe provided lodging and/or meals
The consultai1t will use his/her own materials, i.e., computer/laptop, phone etc.
For the duty travel, the consultant will be providedrented car by HR firm and DSA as per the guideline.
The consultant will bepaid monthly by HR firm upon completion of deliverables as indicated on this TOR and approvedby the supervisor
Policy both parties should be aware of:
ABHPartnersPlc will manageall the administrative issues and aspects based on HR' policies and procedures.
All remuneration must be within the contractagreement through the ABH Partners Plc.
No contractmay commence unless the contractis signed by bothABH 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 UNICEF budget.