Vernon Smith Email & Phone Number
Who is Vernon Smith? Overview
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Vernon Smith is listed as Owner at Black-Smith Consulting, based in Raleigh-Durham-Chapel Hill Area, United States. AeroLeads shows a matched LinkedIn profile for Vernon Smith.
Vernon Smith previously worked as Principal Consultant at Iqvia and Director of Hosting and Managed Services at Foresight Group International Ag. Vernon Smith holds Masters, Internet Security from American Intercontinental University.
About Vernon Smith
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
Vernon Smith's current company
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Vernon Smith work experience
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Principal Consultant
Experienced Director of Cloud Hosting and Consulting specializing in Pharmacovigilance applications. Expert in Oracle Argus Safety, GxP systems, and regulatory submissions. Proven ability to ensure compliant and efficient Pharmacovigilance systems.Key Skills:Strategic Planning: Aligned IT investments with business needs and IT architecture.SDLC Management: Led projects from inception to deployment, ensuring adherence to GxP standards.Pharmacovigilance Expertise: Deep understanding of Adverse Event reporting, Signaling, and regulatory requirements.Oracle Argus Safety: Proficient in configuration, customization, and support.GxP Compliance: Ensured adherence to regulatory guidelines and industry standards.Project Management: Managed internal and external resources for successful project delivery.Vendor Management: Negotiated contracts and maintained strong relationships with vendors.Cybersecurity: Implemented robust measures to protect GxP environments.Continuous Improvement: Led initiatives to optimize application management and support.Achievements:Reduced Electronic Submission support hours by over 35% through process improvements and automation.Developed custom EDI Gateway features that generated additional revenue for hosting services.Successfully represented IT during Health Authority inspections and systems audits.Collaborated with cross-functional teams to implement effective Cybersecurity measures.Provided strong leadership and mentorship to team members.
Director Of Hosting And Managed Services
15+ years of experience in Life Sciences IT, specializing in Drug Safety systems. Proven track record in deploying and supporting systems like ARISg, Oracle Argus Safety Suite, Empirica Signal, and Empirica Topics.Expert in Pharmacovigilance E2B submissions, Health Authority gateway registration guidance, and reporting support.Led successful Oracle Argus Safety 7.x/8.x Cloud Migrations for leading Pharmaceutical companies. Managed the integration of over 20 critical application interfaces.Key responsibilities:Technical planning and execution for Oracle Argus Safety system environments.Ongoing maintenance, upgrades, and support for enterprise applications.Strategic guidance for System Design Specifications, Configuration Baseline, Interface support, and Technical/process requirements.Project management to deliver technical milestones on time, within budget, and to high quality standards.Team leadership and fostering a collaborative environment.Collaboration with Oracle Argus Safety representatives and client stakeholders to optimize system functionality.
Manager Of Safety Systems
Demonstrated exceptional understanding of the Oracle Argus Safety Platform to Support and manage Adverse Event Reporting applications and systems for over thirty five (35) pharma companies.Managed all hosting technology functions aligned with IT architecture and road-map.Collected, analyzed, and documented business requirements and workflows for Adverse Event Reporting using Oracle Argus Safety suite.Led system upgrades and enhancements, including writing and reviewing validation life-cycle documents.Managed daily technical support activities, enhancement requests, and service level agreements.Manage, and execute activities associated with Global PV processes for Computerized Systems Administration, Change Control, and Change Management. Provides data support (e.g., line listings, reports, etc.) for ad-hoc, signal detection, audit, and authority inspection outputs/listings.
Safety System Support Lead/Sme
Senior Lead Support role for Drug Safety systems (ARISg, Argus Safety Suite, and Empirica Trace, SaaS, EAM 2.0, AERs).Subject Matter Expert for EDI gateway submissions for Pharmacovigilance.Lead support for the Technology alignment and integration of critical application interfaces of drug safety systems. Supported Adverse Event Reporting case processing teams using Argus Safety via Citrix connections.Supported ArisG, eAEM, MedDRA dictionaries, and Oracle Argus Safety systems.Provided strategic support for system, configuration, interface support, and technical requirements.Collaborated with application vendors to optimize system functionality and leverage latest updates.
Electronic Media Technical Sme
Manage Electronic Pre-press Research and Development in USAResponsible for system implementation and upgrade support, in the area of emerging pre-press technologies. Managed all LAN/WAN support, installation and upgrades to Switches, Routers, and Hubs and wire installations. Cisco Certified Network Administrator.Recipient of the Guttenberg Printing Award for Electronic Pre-press Technology in 1996
Vernon Smith education
Masters, Internet Security
Bachelors, Infomation Technology
Information Systems And Operations Management
Education record
Frequently asked questions about Vernon Smith
Quick answers generated from the profile data available on this page.
What company does Vernon Smith work for?
Vernon Smith works for Black-Smith Consulting.
What is Vernon Smith's role at Black-Smith Consulting?
Vernon Smith is listed as Owner at Black-Smith Consulting.
Where is Vernon Smith based?
Vernon Smith is based in Raleigh-Durham-Chapel Hill Area, United States while working with Black-Smith Consulting.
What companies has Vernon Smith worked for?
Vernon Smith has worked for Black-Smith Consulting, Iqvia, Foresight Group International Ag, Sentrx, and Pfizer.
How can I contact Vernon Smith?
You can use AeroLeads to view verified contact signals for Vernon Smith at Black-Smith Consulting, including work email, phone, and LinkedIn data when available.
What schools did Vernon Smith attend?
Vernon Smith holds Masters, Internet Security from American Intercontinental University.
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