I am a Drug Safety professional focused on organization, driving results, and accelerating organizational growth through positive leadership, interdepartmental relationship building, process improvement, and change management. I have spent over fifteen years working in the biopharmaceutical industry with a diverse background in Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, and Pharmacovigilance in both human and veterinary products.In-depth knowledge of the following:-Pharmacovigilance: ICSRs, PSURs, Signal Detection and Management, Benefit-Risk Evaluation, RMPs, FDA and Health Canada Reporting, SDEA/PVAs, Electronic Submissions, Literature Searches, CRO management-Regulatory Affairs: Regulatory compliance review. Providing comprehensive regulatory advice with transparency, openness, and consistency.-Quality Management Systems: Building, maintaining, and improving-National Competent Authority Coordination: Lead coordinating FDA, Health Canada, and USDA communications and inspections -Risk Management- Leading risk evaluations based on open discussion and identification of optimal risk mitigation that minimizes internal burdens and maximizes ethical outcomes. -Internal and External Auditing: ASQ CQA- Personnel and project management; Building up strong PV resources and developing effective working relationships with both internal and external partners and direct reports. -Training: Developing, coordinating, and implementing training strategies for cGMP functions. Providing effective training to local and global partners.- Overseeing global and local partner coordination to meet common deadlines and project goals.I have a strong passion for my work and my family. My goals are to leverage my experience to help ensure and improve patient safety while sharing knowledge and helping to build a strong interconnected regulatory and biopharmaceutical community.