National Vaccine Safety Monitoring and Adverse Event Following Immunization (AEFI) Surveillance System Technical Assistance

ABH Partners PLC

To provide technical assistance on COVID-19 vaccine safety monitoring, in the ongoing and routine vaccine vigilance activities, 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

Contract

Addis Ababa,
Addis Ababa

Career Level
Senior Level
Type of corporation
Company size

Location: EFDA (National level)
Duration: 12 months (1st July 2022 to 30 June 2023) with the possibility of extension
No. of consultant: Two
Start Date: July 2022
Reporting to: product Safety Directorate, EFDA

Location: EFDA (National level)
Duration: 12 months (1st July 2022 to 30 June 2023) with the possibility of extension
No. of consultant: Two
Start Date: July 2022
Reporting to: product Safety Directorate, EFDA

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 the assessment that COVID-19 could be characterized as a pandemic. On March 13, 2020, 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. 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 (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 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.

Purpose of the position:

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 pha1macovigilance system and strengthen functional AEFI surveillance system in the country.

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 health care providers (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.
    Prepare periodic and ad-hoc AEFI reports and submit to the stakeholders.
  • 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 repo1is 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, breachers, 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.

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 reporting to 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. The incumbent will also to UNICEF health section COVID-19 vaccine rollout and immunization manger

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, 2020, 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 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 through the use of 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 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.

Purpose of the position:

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 pha1macovigilance system and strengthen the functional AEFI surveillance system in the country.

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, and training on AEFI surveillance system to healthcare providers and immunization/health stakeholders.
Provide training on AEFIs and COVID-19 safety issues for health care providers (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.
Prepare periodic and ad-hoc AEFI reports and submit to the stakeholders.
Ensure the availability of AEFI tools in all health facilities and vaccination site.
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 repo1is from health facilities to the national 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 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 ordered by the national pharmacovigilance center.

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 reporting to 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 the national EPI program. The incumbent will also to UNICEF health section COVID-19 vaccine rollout and immunization manger.

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 rep01i 

submitted.

Bi-annual

Submission of regular monitoring and evaluation reports

Quarterly

Prepared and shared the technical reporting of the mid-term project

Bi-annual

Submission of the final report

Annual

Payment Modality & schedule:

The fees for this contract shall paid on monthly basis based on the submission of monthly reports   against the deliverables indicated above.

Expected educational background and experience:

  • Medical doctor, master’s degree in pharmacy and other public health professionals with 8-10 years of work experience who are interested to work at national level (EFDA).
  • Having basic/advanced Adverse Events Following Immunization (AEFI) surveillance or Vaccine Pharmacovigilance/General Pharmacovigilance training is an advantage.
  • 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