Pharmacovigilance
Building a Global PV Operating Model Without Losing Control
February 3, 2026 • 8 min read
Global coverage adds complexity quickly: jurisdiction variation, timezone handoffs, partner interfaces, and documentation fragmentation.
The control point should be a single operating model with regional adaptations, not region-specific silos.
Practical architecture
- Define a global core workflow with mandatory quality gates.
- Keep market-specific addenda modular.
- Standardize escalation and handoff language.
- Maintain one source of truth for SOP revisions.
Governance rule
Scale only what can be monitored. If a process cannot be measured and reviewed, it should not be multiplied across geographies.
Outcome
Teams gain speed without losing traceability, and regulatory responses stay coherent across authorities.