Get your business sorted in 2026!
Optimise Your Pharmacovigilance Strategy
Expert support for global pharmacovigilance compliance.
About Oakfield Vigilance
Expertise in Pharmacovigilance
At Oakfield Vigilance Ltd, our mission is to ensure patient safety through effective pharmacovigilance. We strive to enhance regulatory compliance and improve healthcare outcomes globally.
We can do this with deep understanding of different regulations across the globe.
Mami Smith
The owner/founder, Mami Smith is a Japanese-English bilingual consultant with an extensive track-record of helping Global-Japan harmonisation for various pharmaceutical companies.
Areas of Expertise
- PV regulatory requirements especially around EMA/MHRA/PMDA/MFDS
- Safety Database implementation/upgrade projects (configuration, migration, validation, business process establishment and training etc)
- Develop and Maintain a Pharmacovigilance System including PSMF for Europe
- Maintain compliance with complicated regulatory requirements across globe including CAPA management
- Procedural document maintenances