LonAdd HR Consultancy Plc (www.lonadd.com) is a Recruitment & Outsourcing Company based in Addis Ababa, Ethiopia, with branch offices in Dukem, Hawassa and Bahir Dar. We are looking to recruit a qualified candidate on behalf of our client.

Location   Sidama, Somali and Amhara region 

No. Required – 3 (Three)

Start date – as soon as possible 

Description

The Ethiopian Food and Drug Authority (EFDA) is the National Regulatory Authority responsible for protecting and promoting public health by ensuring that medicinal products including vaccines are of acceptable quality, safety, and efficacy, are manufactured, distributed, and used in ways that ensure their quality until they reach the patient or consumer, and their commercial promotion is accurate. EFDA, in its mandate given to it through Proclamation 1112/2019, Article 4, Sub-Articles 9 and 10, monitors the safety of medicines including vaccines marketed in the country by analysing their safety data among others to enable evidence-based decision-making. The Authority is also responsible for ensuring the safety and/or quality of food, cosmetics, and dietary supplements as well as to regulate public health aspects of tobacco products.  To carry out its responsibility of ensuring the quality, safety and effectiveness of EFDA regulated pharmaceutical products; the Authority organizes itself into different regulatory functions. 

One of the Authority’s highest priorities is ensuring the quality, safety and effectiveness of medicines, biological products, COVID-19 vaccines and vaccines used in routine immunization. EFDA works to make sure that everyone, everywhere in the country is protected by safe and effective vaccines. To do this, EFDA is working hard to establish rigorous and sustainable safety monitoring systems for vaccines – alongside other medicines and work to develop the strictest standards for their regulation.

Monitoring of adverse events following immunization (AEFI) is an essential strategy for ensuring the safety of vaccines. AEFI surveillance system utilizes tools such as guidelines and procedures geared to assure public health protection through the use of vaccines with proven safety and quality. Currently, the system for monitoring medicine safety (pharmacovigilance) is being coordinated by the National Regulatory Authority (NRA)/EFDA under Pharmacovigilance and Clinical Trial Lead Executive Office. The Authority is working hard to protect the public from preventable adverse events of medicines/vaccines. To achieve this, hiring technical assistance personnel is necessary. 

Therefore, the technical assistance for COVID-19 and RI Vaccine safety monitoring 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 in order to support the everyday management and implementation of robust vaccine pharmacovigilance system and strengthen functional AEFI surveillance system in the country. 

Roles and Responsibilities

• Receive Covid-19 and RI Adverse Events Following Immunization (AEFI) from the healthcare workers and the community

• Collect AEFI line lists of Covid-19 and RI from zones/ woredas/health facilities, check its completeness and submit to pharmacovigilance center

• Participate and coordinate AEFIs from RI and Supplementary Immunization activities (SIAs) 

• Coordinate and support the catchment health facilities HCPs for reporting of Covid-19 and RI AEFIs and other safety related events.

• Coordinate advocacy, training on Covid-19 and RI AEFI surveillance system to healthcare providers and different stake holders. 

• Prepare for and deliver training on identification and reporting of pharmacovigilance for medicines and AEFI for vaccines to health care workers and other stakeholders

• Advocate and participate in public education on the safety of medicines and vaccines.

• Sensitization of public and healthcare workers on reporting of suspected Adverse Events associated to the use of medicines and vaccines.

• Take part in  investigation process of serious AEFI and other eligible cases with other investigation team members

• Prepare and submit monthly, quarterly, biannual and annual Covid-19 and RI AEFI report on time

• Provide capacity building training to health care professionals at regional/zonal/woreda/health facilities

• Participate in vaccine safety and pharmacovigilance monitoring system review meetings, workshops and trainings

• Provide technical input in the development of pharmacovigilance and AEFI surveillance sub national plan

• Ensure the availability of AEFI monitoring tools in all health facilities and vaccination sites.

•  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 Covid-19 and RI AEFI reports, other records and database.

• Conduct regular supportive supervision, provide feedback and follow up of regions/zones/woredas/health facilities on AEFI monitoring activities

• Participate in active vaccine pharmacovigilance surveillance activities identified by the Authority.

• Prepare and disseminate vaccine pharmacovigilance communication tools such as regular newsletters, bulletins, brochures, 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, training materials and other essential tools. 

• Coordinate the identification, assessment and management of any risks associated with vaccines

• Conduct an individual case safety Reports (ICSRs) entry and ICSRs vigilization

• Collect Adverse Event Reports (ADR) from health facilities, summarize and send the reports to the national pharmacovigilance center 

• Coordinate and participate on spontaneous pharmacovigilance monitoring system other than vaccines 

• Conduct other activities ordered by the national pharmacovigilance center/regions/zones accordingly

Appointing Agency

Ethiopian Food and Drug Authority (EFDA) in collaboration with Federal Health Minister (FMOH) and World Bank.

Accountability and place of assignment 

The Technical Assistance for COVID-19 and RI Vaccine safety monitoring will be assigned in the regional or zonal levels and will be ordered by consecutive regions/zones and/or the Pharmacovigilance team under pharmacovigilance and Clinical Trial Lead Executive Office of EFDA. In addition, the technical assistance should have smooth technical communication and relation between the woreda, zone, region and national EPI program.

Job Requirements

Expected Background and Experience

• University Degree in pharmacy, medicine, nursing or health officer with a minimum of 3 to 5 years’ experience who are interested to work at regional 

• Training and/or CPD certificate in basic and/or advanced Adverse Events Following Immunization (AEFI) surveillance or vaccine pharmacovigilance

• Work experience in regulatory areas or pharmacovigilance is an advantage

• Experience in ICSRs entry, reporting via Med safety or vigihub or by other means is an asset

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 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. 

How To Apply

Interested applicants with the appropriate qualifications and experience should submit their most recent and detailed CV only, via email to recruitment@lonad.com , by putting Application for ‘’ Sub national COVID-19 and RI Vaccine Safety Monitoring Technical Assistance (TA) ‘’ in the subject box.

Only Shortlisted Candidates will be contacted

Application Deadline: May 2, 2025