Pharmacovigilance (PV) Services
End-to-End Drug Safety & Risk Management for Global Compliance
Get Free PV ConsultationPharmacovigilance (PV) is the foundation of patient safety and regulatory trust. At Medwisdom, we provide comprehensive PV solutions that ensure every product you market meets the highest global standards.
Our Pharmacovigilance Capabilities
Complete drug safety services from case processing to global regulatory reporting
1. Safety Data Collection & Case Management
- Individual Case Safety Reports (ICSR) – all sources
- Medical review & causality assessment
- Follow-up with HCPs/reporters
- Global regulatory reporting (E2B R3)
- Signal identification & analysis
2. Signal Detection & Safety Monitoring
- Trend analysis & data mining
- Benefit-risk evaluation
- Signal validation & prioritization
- Safety communication
- Label update coordination
3. Risk Management & Safety Documentation
- Risk Management Plans (RMPs)
- PSUR / PBRER / DSUR / ACO
- Safety narratives
- Signal evaluation reports
4. PV System Setup & Compliance
- Full PV system establishment
- SOPs, templates & database setup
- QPPV / LSO services
- Mock audits & inspection readiness
5. Literature Monitoring
- Weekly global literature search
- Indexed & non-indexed journals
- Case screening & review
6. Post-Marketing Surveillance (PMS)
- Trend analysis & registries
- Consumer feedback studies
- Safety label updates
Global PV Standards We Follow
We align with the world’s most authoritative pharmacovigilance guidelines
ICH E2 Series
Global safety reporting & documentation standards
WHO PV Guidance
Global structure for safety systems
EMA GVP Modules
EU Good Pharmacovigilance Practices
U.S. FDA Safety Reporting
Post-marketing safety & REMS
Why Choose Medwisdom for PV?
Trusted by global pharmaceutical companies for audit-ready, compliant pharmacovigilance
Fully Compliant Global PV System
Built to ICH, GVP, WHO & FDA standards
Experienced Safety Physicians
Medical reviewers & regulatory experts
End-to-End Coverage
ICSR, PSUR, RMP, signal detection — all in one
Audit-Ready & Proven
Clean systems trusted by regulators
Multi-Category Expertise
Pharma, biologics, vaccines, devices, cosmetics
Fast & Cost-Effective
Accurate, fast, and competitively priced
Ready for Audit-Ready Pharmacovigilance?
Let our experts build or manage your complete PV system — with zero findings in audits.
Book Free PV Consultation Now