Best practices for pharmacovigilance safety data management

How to ensure rigorous and timely adverse event reporting from diversifying safety data

Pharmacovigilance (PV) data management is rapidly evolving, and pivotal to the success of a PV program. In this comprehensive white paper, we review how safety data management operations have evolved and been transformed by digitization, automation and artificial intelligence. We review how PV programs can adapt to increasing volumes and diversity of data while maintaining adherence to rigid regulatory reporting and data quality standards.

What you’ll learn

Read UBC’s white paper: Best practices for pharmacovigilance safety data management, to understand:

• How PV data management has evolved over time with a focus on the transition from spontaneous reporting of adverse events to proactive solicitation of cases from electronic sources of health data.
• Expert guidance on the eight essential challenges facing PV data today including how to ensure all relevant safety data is included, all irrelevant safety data is excluded, and how hidden safety signals can be identified and validated.
• Overarching best practices for pharmacovigilance data-management including:
  • Guidance for designing data management systems around regulatory compliance
  • How centralized tracking of PV activities and real-time data transforms operational decision-making
  • Understanding where to prioritize investments in human expertise
  • Understanding how to scale PV operations with AI and automation without compromising data quality

Our expertise

UBC’s Global Pharmacovigilance Solutions team brings extensive experience in pharmacovigilance, risk management, and safety signal detection across diverse product types, including drugs, cellular and gene therapies, vaccines, and medical devices. With over 70 companies supported in implementing and managing more than 78 PV programs in the last five years, UBC delivers real-time insights and purpose-built technology to safeguard product safety and regulatory integrity.

Fill out the form for the white paper, Best practices for pharmacovigilance safety data management for holistic insights on safety data management from book-in to signal reporting.