Ohio State Global One Health (GOH LLC) is an affiliate entity of The Ohio State University working extensively on a range of One Health-related projects targeting laboratory, surveillance, and healthcare (both human and animal) system strengthening, workforce capacity building, training, and research in Ethiopia. The Adverse Event Following Immunization (AEFI) is the project GOH has been collaborating with the Ethiopian Food and Drug Authority (EFDA) in efforts of strengthening the national pharmacovigilance system with particular emphasis on safety surveillance of Covid-19 vaccines. As part of this collaboration and system strengthening, the project seeks to hire a Pharmacovigilance data manager who will build core systems and operational capability to successfully gather, analyze, compile, and submit regulatory information for EFDA.

Employer: Ohio State Global One Health, LLC

Duty Station: Ethiopian Food and Drug Authority (EFDA), Addis Ababa, Ethiopia

Employment type – Full-time one-year contract

Number required: One

Line of responsibility - The pharmacovigilance data manager will report to Product Safety Directorate Director of EFDA and AEFI project coordinator

Position Summary:

• The pharmacovigilance (PV) data manager will be seconded to EFDA and will contribute to have a secure and efficient safety/regulatory data management system to ensure greater product oversight and interoperability within the organization. Integrated with organization’s team, s/he will build capacity to the utilization and harmonization of data as part of the regulatory process for an information management-driven approach. 

Roles and Responsibilities

• The position holder will serve as data manager for the EFDA pharmacovigilance team and will have the following responsibilities:

• Work in the development and use of data systems for Adverse Drug Events (ADEs) and Adverse Events following Immunizations (AEFIs) surveillance and monitoring

• Developing quality controls and tools for collecting, entering, editing, cleaning, storing, validation, archiving, retrieving, organizing, and transferring of regulatory/safety data

• Carrying out data review, validation, and report generation of safety related information generated from the routine reporting system, active surveillance and operational studies  

• Implementing and enforcing regular data security activities such as storage, backups, archiving and user administration and addressing demands that arise

• Maintain authority’s databases as required including ensuring regular updates, cleaning, backups and archiving and ensure all related records and reports are handled and managed in line with data governance protocols within the organization

• Conduct data analysis and interpretation regularly for timely use, action, and sharing to national and international stakeholders as per EFDA requirement

• Provide necessary support and engage with technical team in preparing standard reports and scientific documents as needed

• Liaison with teams managing server to foster harmonization of key data management system across units

• Prepare internal progress reports regularly to demonstrate activity progress to the leadership and PV team

• Ensure institutional and national data policies are applied for proper data management and sharing

• Support safety data entry to the global data base through the VigiFlow

• Collect and compile reports on AEFI investigation and causality assessment

• Receive and compile safety data from surveillance sites on daily bases during vaccination campaigns

• Perform other duties and responsibilities as assigned by the supervisor 

Job Requirements

Required Qualification and Experience

• MSc degree in Biostatistics, Statistics, Epidemiology, Health Informatics, Information Science, or other health related field of study from an accredited university with at least five (5) years of relevant experience as a data manager in public health regulatory system or related areas; experience in pharmacovigilance is a plus.   

Adjunct skills Required

• Excellent communication (written and oral) and strong interpersonal skills

• Professional fluency in English required

• Able to work under strict deadlines and deliver deliverables

• Proficiency in Microsoft Office 365, advanced Excel, Word, and PowerPoint; and skills in one of R/ Stata/SPSS/Python, MS SQL are desirable

• Strong analytical and conceptual skills and the ability to think and plan strategically

How to Apply

Register using the following LINK