Patient safety is at the heart of pharmacovigilance. Q-support provides flexible and pragmatic pharmacovigilance support tailored to your organisation, products and needs. Whether you require support for a specific activity, additional expertise for your team or a long-term partner, we help you maintain a robust and compliant pharmacovigilance system.
You will contract Q-support for:
- Local Contact Person for Pharmacovigilance (LCP) role in the BeNeLux
- Pharmacovigilance Quality Management System implementation and maintenance
- (s)PSMF implementation and maintenance
- Pharmacovigilance training
- Audits of local pharmacovigilance activities
- Literature screening support
- Medical Literature Monitoring support
- xEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) maintenance
- Risk Management Plan (RMP) preparation
- Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER) preparation
- Company Core Data Sheet (CCDS)/Company Core Safety Information (CCSI) preparation and maintenance
- Local adaptation and preparation of risk minimisation materials
- Local adaptation and preparation of DHPCs (Direct Healthcare Professional Communications)
- Safety-related regulatory responses and medical writing
- Review of safety-related changes to local product information
- (Addendum to the) Clinical Overview preparation
- Module 2.4 (Non-clinical Overview) preparation
- Module 2.5 (Clinical Overview) preparation
- …
