ICSR Management & Medical Review
Pharmacovigilance
According to EU Directive 2001/83/EC and EU GVPs, pharmaceutical companies must appoint a Qualified Person for Pharmacovigilance (QPPV) who resides in the EU, is continuously available, and has the authority to oversee the company’s pharmacovigilance system.
PVpharm offers comprehensive ICSR management services, from case intake to medical review and regulatory submission, ensuring compliance with EMA, FDA, and national authority requirements.
Our services include:
- Case Intake and Data Entry: Collection and processing of ICSRs from all sources (spontaneous, clinical trials, literature, etc.).
- Narrative Writing: Clear, medically accurate narratives aligned with case details and regulatory expectations.
- Medical Review: Assessment of case seriousness, causality, and completeness by qualified medical professionals.
- Regulatory Reporting: Timely submission of ICSRs to EudraVigilance, FDA (FAERS), and national authorities, including follow-ups when required
- Quality Control: Rigorous checks to ensure data accuracy and compliance with MedDRA coding and regulatory standards.
