County Dublin, Ireland
Lead the strategy, development, and governance of global safety and pharmacovigilance (PV) systems to ensure regulatory compliance and enhance patient safety. Manage the STS Oversight Team responsible for PV technology projects and the overall PV systems roadmap. Partner with business and delivery teams to implement automation and other technologies that streamline PV processes, while ensuring all systems comply with Syneos SOPs and computer system validation regulations. Collaborate with vendors and external partners, contribute to software and system evaluations, build business cases for new or enhanced solutions, and provide training and guidance to stakeholders. Continuously monitor evolving regulations and industry best practices to drive ongoing improvement of safety systems.
• Manage a global team responsible for PV Systems Development and Reporting, including: - the design, delivery and support of bespoke PV applications and associated processes that support QC, Regulatory Reporting, Case Processing, Medical Information, Signal Management, Aggregate Reporting, PV Agreement and Literature teams - providing complex query and reporting support for end users - developing and implementing custom reports for end users and clients - extraction of data and performing data analysis for end users and clients • Ensure systems development adheres to IQVIA SOPs and regulators’ computer system validation guidelines • Work with business leads to develop business cases for new systems and/or changes to existing systems • Responsible for the PV systems roadmap • Partner with other delivery teams to deliver automation/other technologies that streamline PV processes • Contribute to the governance model for PV systems • Participate in new software/systems evaluations
• Architect/Lead Developer of several CFR Part 11 compliant PV applications that support 200+ clients • Configuration, implementation and maintenance of Argus Safety Suite versions 5 and 7.0.X • Create routine and ad-hoc queries that run against Argus Safety versions 5 and 7.0.X • Lead Architect/Developer of several 21 CFR Part 11 compliant PV systems including many that are integrated with the Argus Safety Database • Development of a suite of PV dashboards that monitor KPI, metrics and compliance.
- Custom PV Application Development to support Medical Information and Regulatory Reporting functions - Argus Safety Db Support • Extensive knowledge of the Argus application and database. • Resolve incidents and perform Argus troubleshooting. • Perform User Account Maintenance. • Argus Console maintenance, including study configuration, code list management, field validations, ICSR checks, reporting destination maintenance, etc. • Report monitoring/management. • Generate ad hoc Oracle SQL queries.
• Oracle Forms/Reports development