Accomplished Director of Pharmacovigilance IT Cloud Hosting with a proven track record of delivering successful IT projects and optimizing operations within regulated environments. Over 20 years of experience in FDA 21 CFR Part 11 compliant systems, project management. Skilled in business relationship management, road-mapping, and global project leadership. Proven ability to drive process standardization, and lead cross-functional teams to achieve strategic objectives, implementations and management of Oracle Argus Safety Platforms within complex global pharmaceutical environments.Leveraging deep expertise in GxP and FDA 21 CFR Part 11 compliant systems, project management, and leading high-performance teams, I have successfully delivered end-to-end Pharmacovigilance and risk management solutions for diverse clients. In-depth knowledge of Oracle Argus Safety Systems, coupled with a strong understanding of global regulatory landscapes, enables me to optimize operational efficiency, mitigate risks, and ensure regulatory compliance.Demonstrated ability to collaborate effectively with cross-functional teams, including QA, Clinical Operations, and Regulatory Affairs, to deliver innovative solutions that enhance drug safety processes and drive business value.Key strengths include:Strategic planning and execution of complex IT projectsExpert-level knowledge of Oracle Argus Safety Platform and GxP complianceExpert-level knowledge of Regulatory Health Authority E2B submissions and regulationsProven leadership and team management skillsStrong analytical and problem-solving abilitiesAreas of Expertise Oracle Argus Safety Platform | EDI Systems Integration | GxP Systems Management | Application Implementation and Performance | Project Management Excellence | Team Development and Collaboration |Electronic Regulatory Submissions for PV | Systems Vulnerability Management | Pharmaceutical IT | Computerized Systems Validation | Global IT Management | USA and European Safety Regulations | Systems Monitoring