Bio

Expertise and knowledge in Clinical Pharmacy, Drug Safety/Clinical Trials, Chapter 21 Code of Federal Regulations specifically relating to drug safety post-marketing and clinical trials responsibilities. Global experience in Pharmacovigilance Quality Risk Management / Risk Evaluation and Mitigation Strategies and Risk Management Plans. Multi-industry experience including pharmaceutical and healthcare facilities, and systems. End-user training for e-Learning and web-based applications including training manual design based on client and user specifications. Excellent project management, organization, presentation, and facilitation skills. Technical writing including SOPs and user requirements for new applications. • Quality Risk Management for Pharmacovigilance • Risk Evaluation and Mitigation Strategies (REMS) • Risk Management Plan • Drug Safety Compliance • Quality System for Pharmacovigilance • Project Management/Quality Management • GVP / CSV Risk based Audit • Inspection Readiness • Good Clinical Practice Quality Assurance • Technical and Medical Writing • MedDRA coding/ARGUS/ARISg • Signal Detection • Validation and Drug Safety System Risk • Validation strategies in Pharmacovigilance • Risk Management Compliance • Vendor Management and Oversight • Quality Management System Registered and licensed Pharmacist in NJ kelhoregy@gmail.com