Randy has 30 years of experience working with large pharmaceutical firms, biotechnology, medical device, CROs, hospital corporations, and the US FDA.  Randy managed the Pharmacovigilance system selection, implementation, upgrades and validation.  With experience in both Agile and Waterfall methodologies, along with a strong scientific academic background, utilizing strong documentation and quality orientation, with deep domain and technical systems experience. 

Among his many projects, Randy led the planning and documentation activities for a high-profile migration of data from the legacy ARISJ system utilized by the Japanese affiliate of BMS into ArgusJ Safety. Focusing on analysis of business processes related to receipt, processing and reporting of drug adverse event reports, desired changes to these processes, gap analysis comparing the legacy system and the proposed migration to the target system.  He managed the project documentation and Quality involving business process analysis, authoring of GAMP5 validation rationale and risk documents. With full GxP systems validation as well as the installation/validation of a Backwards/Forwards Compatibility (BFC) tool as an interim solution to the transition between E2B R2 and R3.  The GxP validation work involved authoring, development and management of all GxP validation documents including Risk Analysis, GAMP5 validation rationale, Validation Project Planning (VPP) User Requirements (URS), User Acceptance Test scripts (UAT) and Requirements Traceability Matrix (RTM)   Randy holds a Ph.D. Biology from the University of Miami, an M.A.in Biology and Computer Science, and a B.S., Statistics/Biology from Indiana State University, Terre Haute, IN.

Experience: Oracle Argus 8.1.2 implementation; Oracle ArgusJ Safety system data migration planning; Pharmaceutical Manufacturing Process Quality Informatics; ELN - LIMS system selection; Clinical Systems Report Writer; Emprica and Cognos Reports; Senior Business Analyst / Pharmacovigilance Specialist