Background: Functional pharmacovigilance system is vital to ensure patient safety in the healthcare rnsystem. In the Ethiopian context, there is paucity of information on the organizational functionality rnof the pharmacovigilance program. rnObjectives: To assess the Pharmacovigilance system and implementation status in Ethiopia rnMethod: An institution-based mixed study design was used to assess the pharmacovigilance rnfunctionality at hospitals, pharmaceutical companies, and regulatory authority. World health rnorganizationâ€™s pharmacovigilance indicators and key informant interviews were used for data rncollection. Quantitative and qualitative data were analyzed using Microsoft excel (2013) and rnthematic analysis approach, respectively. rnResults: Only 1 (3.3%) of the 30 hospitals had pharmacovigilance unit with dedicated budget, 3 rn(10%) had staff assigned, and 7 (23.3%) had SOP. Similarly to hospitals, out of 32 pharmaceutical rncompanies 4 (12.5%) had separate pharmacovigilance unit, 12 (37.5%) had regulatory unit, and 5 rn(15.6%) had budget for Pharmacovigilance. The national pharmacovigilance center have most of the rnstructure, process, and outcome level pharmacovigilance practices. As significant challenges, rnresource constraints and reporting-related issues were identified. Patient harm, loss of confidence rnand trust, increased circulation of unsafe products, and economic costs reported as significant rnconsequences. Sector experts recommended increasing training, engaging sector stakeholders, and rnimproving the regulatory system as key interventional strategies. rnConclusion: There are substantial variations in the structures, processes, and outcomes of rnpharmacovigilance status among the studied organizations. Most pharmacovigilance system rnindicators are absent in the majority of pharmaceutical companies and hospitals. However, most of rnthe elements of Pharmacovigilance systems are exercised by the national regulatory authority.