Ebinyo Nelson

Experience

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  Assene-Laborex Limited

  Aug 2010 - Aug 2012

  Drug Safety and Pharmacovigilance Officer

  Drafted and managed periodic safety update reportsAssessed and distributed pharmaceutical product adverse event documents.Reviewed production processes and identified potential quality issues.Recorded and reported adverse reactions received from healthcare professionals andconsumers to regulatory agencies and conducted follow-upsPreparing PSURs on DrugsReviewed pharmacovigilance aspects of clinical trials protocols and reconciled information inpharmacovigilance and clinical research database. Show less

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  University of Port Harcourt Teaching Hospital

  Aug 2012 - Jan 2014

  Quality Assurance and Quality Control Manager

  Identifying regulatory compliance issues and bringing them to the attention of managementPerforming pharmacist responsibilities as outlined by pharmacist protocolsAssisting in the development and implementation of quality improvement processes to monitor the effectiveness and quality of pharmacists' servicesAssisting in the development, support, and monitoring of disease management and drug utilization programsAssisting with the development and implementation of various drug and disease management protocolsWorking in collaboration with interdisciplinary teams across the health systemPerforming literature searches and enabling dissemination of current data on treatment modalities Show less

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  Niger Delta University

  Nov 2015 - Sept 2019

  Lecturer/Department Coordinator

  Contact/teaching time with studentsWriting research proposals and scientific papers and publishing them in peered reviewed journalsAttending and speaking at conferences and seminars and managing research budgetsDeveloping learning materials and maintaining records to monitor students' progressDesign, develop, and offer courses (online and in-person) in pharmacology, toxicology, clinical pharmacy, and biotechnology.Managing departmental budgetsDeveloping exams, quizzes, and homework assignments and providing timely feedback on student work. Show less

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  CBI Health

  Oct 2019 - now

  Managed practical action plans to respond to audit discoveries and compliance violations.Maintained up-to-date knowledge of current and emerging compliance regulations.Reviewed, revised, and updated compliance policies and procedures to confirm continual compliance with applicable laws.Identified, investigated, and documented compliance violations and recommended corrective measures.Enforced regulatory and company policy compliance to improve workplace and employee safety and readiness. Show less

  • Operations Manager

    Jun 2024 - now

  • Operations/Compliance Supervisor

    Oct 2019 - Jun 2024
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  Northeastern University

  Sept 2022 - Dec 2022

  Regulatory Affairs Intern

  Interpreted regulatory rules or rule changes and communicated with SponsorsReview labels for accuracy and regulatory compliance Updated Standard Operating Procedures, Work Instructions, and PoliciesDeveloped Clinical Monitoring PlanDeveloped FDA Inspection Readiness SOPDeveloped Regulatory Strategy for marketing a novel medical devicePrepared and submitted regulatory file applications and supporting documentation.Demonstrated ability to work collaboratively and effectively in completing tasksLearned and adapted quickly to new technology and software applications.Developed and tracked quality metricsPrepared and submitted regulatory file applications and supporting documentation. Show less