Backgraound
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: 7
Duty station: Oromia
Salary: Attractive
Level: NOB
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.
2. Purpose
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
4. Expected Deliverables and Time frame
Deliverables | Deadline |
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. | Quarterly |
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 | Bi-annual |
Conducted cascade training 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 |
Facilitated the implementation of the revise technical guideline for carrying out vaccine efficacy studies against COVID19 | Bi-annual |
Prepared and submitted a regular monitoring and evaluation reports. | Quarterly |
Prepared and shared the mid-term technical report. | Bi-annual |
Submission of final report. | Annual |
5. Reporting
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 aboveKey competence
Note:
Policy both parties should be aware of: