Pharmacovigilance Expertise, Built Around Your Needs
From clinical development to post-marketing surveillance, Phoenovix provides senior-led, fit-for-purpose safety services designed around your product, portfolio and organizational stage.
Clinical Safety
Supporting patient safety throughout clinical development
SAE and SUSAR processing/support
Safety monitoring and reconciliation
Clinical safety workflows and governance
DSUR coordination and support
Post-Marketing Pharmacovigilance
Dependable safety surveillance for marketed products and portfolios
ICSR processing and quality control
Literature surveillance
Reconciliation and compliance monitoring
Regulatory safety submission support
Signal, Benefit-Risk & Risk Management
Turning accumulating safety evidence into informed safety decisions
Signal detection and evaluation support
Benefit-risk assessment
Risk Management Plans
Safety strategy and regulatory responses
Safety & Regulatory Writing
Scientifically robust safety documents, developed with rigorous review
Aggregate reports including PSUR/PBRER/DSUR
Signal evaluation reports
Addendum to Clinical Overview
Case narratives
Health authority query response
PV Quality & Governance
Building controlled and inspection-conscious PV capabilities
PV QMS and SOP development
Deviations and CAPA support
Inspection-readiness assessments
Roles, responsibilities and governance frameworks
Role-based PV training
Strategic PV Consulting & Fractional Leadership
Senior PV expertise without adding permanent infrastructure
