Brad Gallien | Technology Enablement Director – PV Compliance Systems
Genentech
I have over 30 years’ experience applying state of the art technology solutions to the Clinical R&D sector of the biopharma and medical device industry. I’ve been with Roche/Genentech for 4 years in the role of Technology Enablement Director, Compliance Systems, responsible for identifying and implementing new technology solutions to support our evolving global PV processes for drugs, biologics, ATMPs, and medical devices. Prior to joining Genentech, I spent over 20 years designing, building, and implementing global PV systems at NetForce, Oracle, November Research Group, and Genpact. I started my career in the clinical data management department at Syntex, where I focused on introducing just-in-time data quality checking to expedite study close-out and was the business lead on the development and implementation of the Oracle Clinical system. Throughout my career, I have thrived in bridging the gap between the business requirements and technology solutions, contributing to use case development, detailed systems architecture and design, and development.
Appearances:
Day 1 - World Drug Safety Congress Americas 2025 @ 12:20
Delivering Transformative Results from Promises in an AI-era
Join experienced Pharmacovigilance Systems Leaders to discuss what it really takes to successfully implement reality vs. hype and what's changed with AI. We'll cover navigating overselling during the sales cycle, expectation setting, culture and commitment to change - with plenty of lessons learnt along the way. Not one to be missed for PV systems or business leaders looking for actionable insight from industry veterans representing a diverse set of organizations.
Day 2 - World Drug Safety Congress Americas @ 11:55
Presentation: Modernizing ICSR Management through Multi-Stakeholder Collaboration
The current practice of managing and sharing Individual Case Safety Reports (ICSRs) across the PV ecosystem was established in the 1960s. A new conceptual ICSR management model has been proposed to limit the number of replicates and duplicates in the global PV ecosystem and improve the speed of access to quality data for signal detection1 While there are many challenges with progressing such a vision, the potential opportunities warrant further exploration.
We seek to use this forum to catalyze action - to start the discussion about how a multi-stakeholder group might partner in international collaboration to design, build, and conduct a pilot to modernize ICSR management and scale ownership to a new way of working. We invite stakeholders to consider joining this effort as collaboration is essential to realizing a more efficient and responsive PV ecosystem.
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