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 robust vaccine pharmacovigilance system and strengthen functional AEFI surveillance system in the country.
Harari Region, Ethiopia
Type of corporation
ABH Partners Plc is a leading consultancy and human resources sourcing firm in Ethiopia with about 15 years of experience in supporting the implementation of development programs and projects. ABH exists to fuel synergistic societal growth by harnessing local knowledge and international standard. Dedicated to the betterment of societal development, technical assistance, and knowledge management, ABH has gained credibility and industry experience in the development sector in general. ABH partners would like to invite applicants who meet the below requirements to apply for the position of Sub-national Vaccine safety monitoring and Adverse Event Following Immunization (AEFI) Surveillance system Technical Assistance.
Required Number: 1
Duty station: Harari Region
Duration: 24 months
Reporting to: Product Safety Directorate, EFDA
Expected Start Date: Immediately after concluding the contract agreement
1. Background and Justification
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, 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 its self 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 in particular. AEFI surveillance system focuses on vaccine safety and it utilizes tools such as guidelines and procedures geared to assure public health protection through the use of vaccines with proven safety profile and ensure quality. The current system for monitoring drug safety (pharmacovigilance) 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 be responsible and cover the various activities and deliverables within the introduction of COVID-19 vaccine safety monitoring, in the ongoing and routine vaccine vigilance activities, and in order to support the everyday management and implementation of robust vaccine pharmacovigilance system and strengthen functional AEFI surveillance system in the respective region/zone.
To provide technical assistance on COVID-19 vaccine safety monitoring, in the ongoing and routine vaccine vigilance activities, and in order to support the everyday management and implementation of robust vaccine pharmacovigilance system and strengthen functional AEFI surveillance system in the respective region/zone
3. 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 different stake holders.
Provide training on AEFIs 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 team.
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, HCF, woreda health office, ZHD receiving AEFI reports from health facilities to RHB level.
Maintain Adverse Event Following Immunization (AEFI) reports and other record and database.
Conduct regular supervision and follow up of immunization site
Participate in active vaccine pharmacovigilance surveillance activities
Coordinate implementation of the pharmacovigilance roadmap at sub-national level
Participate in the implementation of vaccine pharmacovigilance directives, guidelines, SOPs and tools.
Coordinate the identification, assessment and management of any risks associated with vaccines
4. Expected Deliverables and Time frame
In-depth desk review conducted of the pharmacovigilance system and preliminary situation analysis report submitted.
Initial and quarterly
Improvement plan developed for the pharmacovigilance system
Initial and bi-annual
Consultation and validation meetings conducted and documented with private and public stakeholders on the improvement plan.
Workshops conducted with key stakeholders to adapt the AESI guidelines to the country context
Initial and bi-annual
Updated training modules to be used for the training of personnel involved in the pharmacovigilance system at the central and regional level
Conducted cascade training pharmacovigilance and vaccine safety surveillance.
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.
Facilitated the implementation of the revise technical guideline for carrying out vaccine efficacy studies against COVID19
Prepared and submitted a regular monitoring and evaluation reports.
Prepared and shared the mid-term technical report.
Submission of final report.
The Technical Assistance for COVID-19 Vaccine safety monitoring and Adverse Event Following Immunization (AEFI) Surveillance will be assigned in the region/zone city of all region based on their specific appointment and will be ordered by the pharmacovigilance and clinical trial team under the product safety directorate of EFDA. In addition, the technical assistance should have smooth technical communication and relation between the woreda, zone, region and national EPI program.
6. Payment Modality and Schedule
The fees for this contract shall paid on monthly basis based on the submission of monthly reports against the deliverables indicated above.
7. Expected background and Experience
Master’s Degree in pharmacy, public health or related field with background degree in health
With a minimum of 8-10 years of work experience at National level (EFDA) in pharmacovigilance, AEFI surveillance, EPI program, vaccine pharmacovigilance or vaccine safety program.
Training certificate in advanced Adverse Event Following Immunization (AEFI) surveillance or vaccine pharmacovigilance
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 vaccine 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 Federal EFDA
The consultant will not be provided lodging and/or meals
The consultant will use his/her own materials, i.e. computer/laptop, phone etc.
For the duty travel, the consultant will be provided rented car by HR firm and also DSA as per the guideline.
The consultant will be paid monthly by HR firm upon completion of deliverables as indicated on this TOR and approved by the supervisor
Policy both parties should be aware of:
HR firm will manage all the administrative issues and aspects based on HR’ policies and procedures.
All remuneration must be within the contract agreement through the HR firm
No contract may commence unless the contract is signed by both HR firm and the consultant.
Travel will be facilitated and managed by the HR firm in agreement with UNICEF.
Consultants will not have supervisory responsibilities or authority on UNICEF budget.