RWE Methods · Pharmacovigilance
Pharmacovigilance and Real-World Safety
Pharmacovigilance is the science of detecting, assessing and preventing the adverse effects of medicines. Real-world data is making it faster and broader.
Safety, signal detection and the real-world data behind them are on the agenda at RWE Connect 2026 in Boston.
Free. Instant download. No obligation.
The sources
The Data Behind Pharmacovigilance
Safety surveillance draws on many streams of data, each catching signals the others might miss.
How it works
The Pharmacovigilance Process
From a first hint of a problem to action, safety surveillance follows a disciplined path.
The shift
How Real-World Data Strengthens Pharmacovigilance
Real-world data is moving safety surveillance from periodic and reactive to continuous and proactive.
The techniques
Signal Detection Methods
Finding a genuine safety signal in a sea of reports takes statistical rigor. These are the workhorse methods.
The rules
The Pharmacovigilance Regulatory Landscape
Safety surveillance operates inside a global framework of regulators, databases and standards.
The hard parts
Challenges in Real-World Pharmacovigilance
Real-world safety data is powerful but messy. Knowing the challenges, and how teams address them, is what keeps surveillance credible. These are the recurring ones, debated at RWE Connect 2026.
The direction of travel
Where Pharmacovigilance Is Heading in 2026
Drug safety is being transformed by AI and real-world data. These are the shifts defining modern pharmacovigilance, and the debates on the agenda at RWE Connect 2026.
Explore
Explore Related Methods
Pharmacovigilance sits within a wider RWE methods toolkit.
Sponsor RWE Connect 2026
Meet the Safety and Real-World Evidence Buyers in Boston
Drug-safety and real-world evidence leaders gather at RWE Connect 2026: 150+ attendees, around 60% at Director or VP level and above.
RWE Connect 2026
Get the RWE Study Methods Primer
A plain-English guide to the core RWE methods, including safety surveillance and signal detection. See the methods, then meet the people applying them in Boston.
- How safety signals are detected
- The data sources behind pharmacovigilance
- Where real-world safety is heading in 2026
Free. Instant download. No obligation.
Pharmacovigilance: Common Questions
What is pharmacovigilance?
Pharmacovigilance is the science and set of activities related to detecting, assessing, understanding and preventing the adverse effects of medicines and other drug-related problems.
What is a safety signal?
A safety signal is information that suggests a possible new causal association, or a new aspect of a known association, between a medicine and an adverse event, warranting further investigation.
What is signal detection?
Signal detection is the process of identifying potential safety signals from data sources such as spontaneous adverse-event reports, electronic health records, claims and the medical literature.
How does real-world data support pharmacovigilance?
Real-world data broadens and speeds up safety surveillance beyond spontaneous reporting, using electronic health records, claims and AI or NLP to enable near real-time, continuous monitoring.
What is FAERS?
FAERS is the FDA Adverse Event Reporting System, a database of adverse-event and medication-error reports. VigiBase is the equivalent global database maintained by the WHO.
How is AI used in pharmacovigilance?
AI is used for natural language processing on unstructured records, automating case intake and processing, and improving signal detection at scale.
What is disproportionality analysis?
A statistical method that flags drug-event pairs reported more often than expected across a safety database, using measures such as the proportional reporting ratio (PRR) and reporting odds ratio (ROR).
What regulations govern pharmacovigilance?
Requirements from the FDA, the EMA (through EudraVigilance), the WHO and ICH guidelines such as E2E govern how adverse events are collected, assessed and reported.
What is a PSUR?
A Periodic Safety Update Report (PSUR, now often a PBRER) is a regular report summarizing a medicine’s worldwide safety data and benefit-risk balance.
When and where is RWE Connect 2026?
14 to 15 October 2026 at the Hampton Inn by Hilton, Boston Seaport District, Boston, MA.
What is signal validation?
Confirming that a detected signal reflects a genuine safety concern rather than statistical noise or a data artefact, before it is escalated for full assessment.
What is causality assessment?
Evaluating whether a medicine likely caused an adverse event, using structured frameworks such as the WHO-UMC system or the Naranjo scale.
What is active surveillance?
Proactively monitoring defined data sources, such as the FDA Sentinel system, for safety signals, rather than waiting for spontaneous reports to arrive.
What is the difference between a PSUR and a PBRER?
Both are periodic safety reports. The PBRER is the ICH-harmonized format that emphasizes an integrated benefit-risk evaluation, and it has largely replaced the older PSUR.
