our expertise

At the heart of our operations is our focus on quality.

We believe in offering creative, innovative ideas and provide a service of excellence to all our customers.

Core Pharmacovigilance Provisions

EU QPPV/Deputy EU QPPV services
Pre and post marketing case management (including submissions)
Literature screening and review
Routine safety surveillance and signal detection
Periodic Report scheduling, production and submission
Risk Management Plans production and tracking of implementation
Pharmacovigilance System Master File (PSMF) preparation and maintenance
Drafting, reviewing, negotiating and maintaining Safety Data Exchange Agreements (SDEA)
- including extended work with Quality Assurance, Business Development and Legal teams regarding link to Technical Agreements and Commercial contracts

If you would like to know more information on how Semper Vigilance can help you, contact us and we can talk through your requirements.