1. New Requirements for Benefit-Risk Assessments
Evolving global pharmacoviglance regulations have recently put the spot-light on finding better and quicker ways to
measure and assess medicinal product benefit-risk profiles through new requirements and guidelines.
Quintiles can help you better understand and comply with these changing regulations through our safety aggregate
reporting and benefit-risk assessment capabilities. Through our experienced staff, best-in-class processes, and proprietary
technology, we are able to deliver medical, scientific and regulatory reports that are timely, insightful, and stand up to
regulatory scrutiny.
Outstanding Pharmacovigilance Delivery
Zero critical findings from customer audits1
99% compliance for on-time reporting to health authorities1
200+ medical and clinical professionals including medical
doctors, pharmacists, and life sciences graduates2
Bringing Together the Right Experts,
Around the Globe
Cross-functional – Our team is comprised of physicians,
pharmacists, pharmacoepidemiologists, and regulatory
affairs professionals (including ex-FDA and European
regulatory agency staff) with a wealth of medical,
pharmaceutical, scientific and clinical expertise.
Highly Trained - All staff are trained and experienced in
drug safety with particular focus on safety and efficacy
analysis and regulatory requirements, to help deliver the
highest quality and performance through our globally
compliant suite of SOPs and templates underpinned by a
range quality checklists.
Global – Our staff is housed across 8 global hubs located
across North America, Europe and Asia. This globalization
of services allows for extensive regionalized expertise,
local-language translation, flexibility, improved cost
effectiveness and provides the ability to meet our client’s
local requirements, while never losing sight of safety and
risk management compliance on a global scale.
1
Source: Quintiles internal data. Metrics valid from November 2012 through
November 2013.
2
Source: Quintiles internal HRPSC data valid as of July 2013.
Safety Aggregate Reporting and Analytics
Team Core Training Modules
Aggregate Reporting Training
Knowledge of Systems and Processes
Training Transcript Review
Subject Matter Expert Mentoring
Specialized Argus 7.0 Reports Training
Individualized One-on-One Reports Training
Subject Matter Expert Mentoring
Project Specific Training
• Product Safety Information (IB, CCDS, CCSI, USPI, SmPC)
Electronic Learning Management
• Safety Aggregate Reporting & Analytics Specific Electronic
Standard Operating Procedure (eSOP) Documents and
Assignments
• Electronic Training (eTraining) Management System
• Required Readings (Regulations/Guidances)
• Report Specific Courses With Knowledge Tests
• Process Maps
• Safety Aggregate Reporting Manual of Style
All team members receive extensive training and mentorship as part
of onboarding and continuing education.
Safety Aggregate Reporting & Analytics
PHARMACOVIGILANCE INSIGHTS
AT-A-GLANCE
