Title: Regional Vaccine Safety Monitoring and Adverse Event Following Immunization (AEFI) Surveillance System Technical Assistance- Harar
ABH Partners PLCPurpose: 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
Senior Level
Location: Harar at 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: 04
Start Date: July 2022
Reporting to: Product Safety Directorate, EFDA and UNICEF
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 theassessment that COVID-19 could be characterized as a pandemic. On March13, 2020 the first confirmedCOVID- 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:
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.
Specific Tasks:
- Collect AEFI reports and other COVID-19vaccine 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, and training 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 sites.
- 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 ordered by the regional pharmacovigilance center.
Reporting:
The Technical Assistance for COVID_19 Vaccinesafety monitoring and Adverse Event Following Immunization (AEFI) Surveillance will be assigned to the regional/zonal EFDA office and will be reported 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:
Deliverables | Deadline |
An in-depth desk review of the pharmacovigilance system was conducted and a preliminary situation analysis report was submitted. | Initial and quarterly |
Submission of an 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 were conducted with key stakeholders to adopt the AESI guidelines to the country context | Initial and bi-annual |
Training modules developed for personnel involved in the pharmacovigilance system the centra l and regional level | Bi-annual |
Regional level ToT was conducted on pharmacovigilance and vaccine safety surveillance. | Quarterly |
Surveillance tools and training modules 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 |
A budget estimate was developed for the five-year pharmacovigilance improvement plan. | Bi-annual |
Technical guidelines was pharmacovigilance reviewed for carrying out vaccineefficacy studies against COVID19 and rep01i submitted. | Bi-annual |
Submission of regular monitoring and evaluationreports | Quarterly |
Prepared andshared the technical reporting of the mid-term project | Bi-annual |
Submission of the finalreport | Annual |
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 final report evaluation reports and shared vaccine efficacy.
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.
Note:
- The consultants will be based at city/regional/zonal EFDA level
- The consultant will not be 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 provided a rented car by ABH Partners and DSA as per the guideline.
- The consultant will be paid 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:
- ABHPartners 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 contracts are 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.