Our Services

Core Pharmacovigilance Services

We provide a full suite of pharmacovigilance services, including . . .

1. EU Qualified Person for Pharmacovigilance (QPPV), Deputy QPPV provision
2. Safety Physician provision
3. Pharmacovigilance System Master File (PSMF) –preparation and maintenance
4. Risk Management Plans (RMP) – preparation and maintenance
5. Signal Management activities
6. Medical Information provision
7. Periodic reporting, including PSURs and safety reviews
8. Literature screening and review
9. Individual Case Safety Report (ICSR) processing EVMPD updates via EVWEB
10. ICSR submission via EVWEB
11. 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
• Training
• Audit of a client’s pharmacovigilance systems
• Local Authority inspection preparation and assistance

Systems Compliance

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