PV PHYSICIANS INC
primum non nocere
Safeguarding Patient Wellbeing With Dedication, Diligence & Integrity
ABOUT
PV Physicians Inc is a physician owned and run corporation that provides consulting services to biotech and pharma companies in the area of patient safety and risk management. With more than twenty years of experience in the pharmaceutical industry, expertise focuses on the physician-driven aspects of pharmacovigilance and ranges from the review of individual case safety reports all the way to integrated benefit-risk assessment throughout a product’s life cycle. Services are tailored to company-wide needs, including design and integration of highly efficient and fully compliant safety organizations. We can help you conceptualize and build an entire department or provide our services à la carte.
MISSION
PV Physicians Inc aims to combine drug safety expertise with values-driven medical decision-making to deliver patient-centered pharmacovigilance and risk management work product and safety solutions.
CORE SERVICES
Safety Evaluation
- Individual case safety reports (ICSR) for clinical trials and marketed products
- Aggregate data (DSUR, PADER, PBRER, etc.)
- Health authority responses
- Health hazard assessments
- Determination of reporting
Signal Detection
- Review of safety observations from multiple sources
- Signal validation, prioritization, tracking, assessment, and characterization
- Signal evaluation medical write up
- Data mining
Risk Management
- Product safety profile characterization (RSI, CCDS, etc.)
- Structured benefit-risk analysis of safety and efficacy data
- Planning for pharmacovigilance and risk minimization activities (RMP, REMS)
- Safety communication, routine and additional