Q1. What is a pharmacovigilance (PV) system?
A PV system is a combined set of processes, people, and technology that a company uses to collect, assess, and act on information about the safety of its drugs after they’ve reached patients, from individual case reports through to signal detection and risk management.
Q2. What’s the difference between case processing and signal detection?
Case processing handles individual adverse event reports one at a time. It involves intake, coding, medical review, and submission.
Signal detection moves across the accumulated database of cases. It finds patterns that suggest a new or changing safety risk. One feeds the other.
Q3. How often should signal detection be performed?
It depends on case volume and product risk. High-volume, established products often run continuous or monthly signal detection. Lower-volume or newly approved products may run it quarterly, alongside periodic safety reporting, with medical review happening more frequently in between.
Q4. Do small companies need the same pharmacovigilance system as large pharma?
They need to meet the same regulatory obligations, but the system itself can be scaled differently. A lean system built around outsourced case processing, cloud-based safety databases, and clear documented accountability can satisfy the same requirements without the infrastructure of a large in-house department.
Q5. What happens after a signal is detected?
It goes through validation to confirm it’s a genuine pattern rather than noise, then prioritization based on its seriousness and the strength of the evidence. Confirmed, high-priority signals move into formal evaluation, which can lead to label updates, changes to the risk management plan, or additional studies.
Q6. What regulatory timelines apply to adverse event reporting?
Timelines vary by jurisdiction and event severity, but, as a general benchmark, serious and unexpected adverse events with suspected drug causality are typically reported to regulators within 15 calendar days of the company’s first becoming aware of them.