PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges

Summary

PATH is seeking a Pharmacovigilance Specialist – Consultant to coordinate the work on pharmacovigilance strengthening to accelerate the introduction of radical cure for P. vivax. The consultant will work closely with National Malaria Control Program (NMCP), Ethiopian Food and Drug Administration (EFDA), other key stakeholders and partners in delivering the responsibilities.

Responsibilities

• Desk review of available pharmacovigilance (PV) guidelines of EFDA /FMOHS
• Review/ assess the current Adverse Event (AE) recording and reporting mechanisms undertaken by EFDA
• Review the existing tools, forms and formats used for AE reporting by other public health programs of MOHS e.g., National TB program
• Conduct SWOT analysis of the Pharmacovigilance system vis-à-vis AE reporting for P. vivax
• Identify and develop SOPs for PV process to record/report AE in relation to P. vivax including identification of current reporting forms and formats of NMCP where these aspects could be built into.
• Identification of capacity building/ training needs on PV at different levels of health systems
• Develop detailed PV strengthening plan with activities, timelines and budget including training needs on PV
• Coordinate and facilitate the stakeholder meetings in relation to this task
• Sharing of the plan with key stakeholders

Required Skills

Required Experience

• Bachelor’s in pharmacy, medicine or public health with advanced degree in pharmacology, public health, drug regulation.
• Minimum seven years’ progressive experience in pharmacovigilance strengthening at national and sub-national levels.
• Experience in using the global tools on the assessment of the PV System.
• Medical writing expertise focusing on writing reports, and safety management plans.
• Understanding of the National and sub- national pharmacovigilance processes and regulations.
• Possesses thorough knowledge on recent pharmacovigilance directive of EFDA.
• Possesses sound understanding of the stakeholders in strengthening pharmacovigilance in Ethiopia.
• Knowledge on malaria control and elimination program including importance of pharmacovigilance strengthening vis-à-vis P. vivax radical cure.
• Excellent oral and written English communication skills.
• Strong interpersonal skills in facilitation and stakeholder engagement/coordination.
• Ability to travel estimated at 30% of the time (depending on COVID-19 situation and if travel is allowed).

Preferred

• Ethiopian nationality
• Residing and working in Ethiopia
• Experience working in or with FMOH and EFDA is highly preferred.
• Prior experience of performing literature review for PSUR inclusion and assessment of literature for ICSRs.

Duration : 37 working days between xx February – xx May 2022

Must have legal authorization to work in Ethiopia.