During the past 19 years, Tony has held Pharmacovigilance and Clinical technology and project/program management roles at Shire, Cubist, Boston Scientific, Millennium, and Bayer. Tony has led projects to establish drug and device safety processes and systems from individual case processing up through management controls and global authorization. He has managed world-wide implementations, integrations and data migration projects for both in-house and externally-hosted systems. Tony has been on both sides of the table for internal and external (partner, vendor) PV System audits, led PV System inspection-readiness initiatives and participated in agency PV System inspections. He has an MBA in Information Technology from Worcester Polytechnic Institute.