Summary of the Position:
Working under the direction and guidance of the USP Chief of Party, the incumbent will be primarily responsible for the coordination for post-marketing safety and quality surveillance activities of the Promoting the Quality of Medicines (PQM) Program in support of the Ethiopian Food, Medicines and Healthcare Administration Control Authority (EFMHACA and other partners in Ethiopia.
The Regulatory Affairs Specialist shall provide technical assistance to strengthen EFMHACA’s pharmacovigilance and medicines safety surveillance activities and support the utilization of unified platform and systems for both safety and quality surveillance for the protection of public health. He/she will work in close collaboration with staff at EFMHACA to build individual and institutional capacity and ensure the establishment of appropriate systems and resources necessary to strengthen EFMHACA’s center for adverse drug reactions (ADR) and pharmacovigilance. PQM’s technical assistance supports EFMHACA to develop strategies that enables different development partners to provide technical or financial support in order to strengthen the pharmacovigilance and medicines safety surveillance as well as quality surveillance systems. The Regulatory Affairs Specialist will assist in the planning, development and implementation of guidelines, frameworks, manuals, newsletters and SOPs and support training efforts on monitoring the quality and safety medicines.
Terms of Employment: Contract
Minimum Requirements
Education and Experience:
Education:
Experience:
Knowledge, Skills and Abilities: