Risk, Legal & Compliance
Pharmacovigilance & Safety Intelligence
AI-accelerated case processing, continuous adverse event signal detection, and automated safety reporting.
About this playbook
Pharmacovigilance case processing is manual, high-volume, and subject to strict timelines. This playbook redesigns safety operations for AI-accelerated case triage, continuous signal detection, and automated aggregate reporting.
Key outcomes
- Reduce ICSR processing time through AI-assisted case triage, coding, and narrative generation
- Detect emerging safety signals earlier through continuous, AI-driven disproportionality analysis
- Automate aggregate report preparation (PSURs, DSURs) to reduce manual assembly effort
What's inside
Playbook structure
Every Silver Brain playbook follows the same 13-section structure, ensuring consistency and comparability across functions.
01AS-IS diagnostic — how the function currently operates
02Value gap analysis — where AI creates the most leverage
03AI-native target operating model (TOM) overview
04Workstream 1 design — detailed process and tooling
05Workstream 2 design — detailed process and tooling
06Workstream 3 design — detailed process and tooling
07Workstream 4 design — detailed process and tooling
08Workstream 5 design — detailed process and tooling
09Tool landscape assessment — build, buy, and integrate
10Data and integration architecture
11Governance and operating rhythm design
12Phase 2 build guide — sequencing and scoping
13Success metrics and value realisation framework
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