National Vaccine Safety Monitoring and Adverse Event Following Immunization (AEFI) Surveillance System Technical Assistance
ABH Partners PLCTo 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.
attractive
Contract
EFDA (National level), Ethiopia
Addis Ababa, Ethiopia
8-10
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 National Vaccine Safety Monitoring and Adverse Event Following Immunization (AEFI) Surveillance System Technical Assistance.
Required Number: Two
Duty station: EFDA (National level)
Salary: Attractive
Level: NOC
Duration: 24 months
Reporting to: Product Safety Directorate, EFDA
Expected Start Date: Immediately after concluding the contract agreement
- 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 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 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 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 country.
2. Purpose
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.
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 immunization/health stakeholders.
- 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 AEFI team of EFDA.
- PrepareAEFI 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, regional health bureau, EFDA and Ministry of Health for receiving AEFI reports from health facilities to national level.
- Maintain Adverse Event Following Immunization (AEFI) reports and other record and database.
- 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, broachers, letter to healthcare professionals, media communication.
- Coordinate implementation of the national 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 national pharmacovigilance center.
4. Expected Deliverables and Time frame
| Deliverables | Deadline |
| In-depth desk review of the pharmacovigilance system conducted and preliminary situation analysis report submitted. | Initial and quarterly |
| Submission of improvement plan for the pharmacovigilance 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 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 at the central and regional level | Bi-annual |
| National level ToT conducted on 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 |
| Technical guideline reviewed for carrying out vaccine efficacy studies against COVID19 and report submitted. | Bi-annual |
| Submission of regular monitoring and evaluation reports | Quarterly |
| Prepared and shared the technical report of the mid-term project | Bi-annual |
| Submission of the 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 EFDA office 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 with RHB 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
Key competence
- 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.
Note:
- 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.