Core Pharmacovigilance Services
We provide a full suite of pharmacovigilance services, including . . .
- EU Qualified Person for Pharmacovigilance (QPPV), Deputy QPPV provision
- Safety Physician provision
- Pharmacovigilance System Master File (PSMF) –preparation and maintenance
- Risk Management Plans (RMP) – preparation and maintenance
- Signal Management activities
- Medical Information provision
- Periodic reporting, including PSURs and safety reviews
- Literature screening and review
- Individual Case Safety Report (ICSR) processing EVMPD updates via EVWEB
- ICSR submission via EVWEB
- Safety Data Exchange Agreements (SDEA) set up and maintenance
Quality Management & Auditing
Quality is at the heart of our operations. We have a dedicated Quality Manager, and deploy a range of techniques to ensure that every facet of work done for clients is delivered faultlessly.
- Use of Panacea’s complete set of SOPs
- SOP review and writing – company specific
- Audit of a client’s pharmacovigilance systems
- Local Authority inspection preparation and assistance
We have extensive experience of ensuring systems compliance.
- Infrastructure and validated Database
- Setting up and maintenance of EudraVigilance accounts
Communication and Management
We are responsive both in day-to-day communications, and act swiftly when alerting clients to key issues, or in crisis situations.
- Responding to enquiries from Authorities
- Identifying and communicating changes to Benefit / Risk
- Crisis Management