The Drug Safety Lifecycle · Section 3.6
~5 min read · The Drug Safety Coach — Global PV Career Course
Key points
Who owns what, at each lifecycle stage
| Stage | Industry Responsibility | Regulatory Role | Key PV Activities |
|---|---|---|---|
| Preclinical | Nonclinical scientists, toxicologists | Regulatory reviewers (HA) | Toxicological screen, ICH M3(R2) compliance, safety pharmacology |
| Phase I–III (Clinical) | Sponsor/CRO safety teams, investigators | IRB/Ethics Committees, Health Authorities | SUSAR reporting (7/15-day), DSUR (annual), DSMB review |
| Regulatory Submission | QPPV, Regulatory Affairs, Medical Affairs | EMA/FDA/CDSCO reviewers, PRAC | RMP finalisation, benefit-risk dossier, label negotiation |
| Post-Marketing (Early) | Drug Safety Associates, Safety Physicians | Health Authorities, Signal Teams | Expedited ICSRs (15-day), signal detection, PBRER submission |
| Post-Marketing (Mature) | Senior PV, Signal Analysts, Epidemiologists | PRAC, FDA Sentinel, HA Inspectors | Continuous signal management, PASS/PAES, RMP updates |
| Lifecycle Maintenance | QPPV, PV Directors, Compliance Teams | Regulators (Inspections, Audits) | PSMF maintenance, audit programme, CAPA management |
Full text
Pharmacovigilance activities are distributed across multiple functions and stakeholders throughout the lifecycle — but they converge under a single purpose: patient safety. Understanding who is responsible for what, and when, is essential for both operational efficiency and regulatory compliance.
The table above is worth memorising less for its individual cells and more for the pattern it reveals: responsibility moves from scientific/technical roles (toxicologists, investigators) toward increasingly cross-functional, senior, and compliance-oriented roles (QPPV, PV Directors) as a product matures. A fresher’s first job is almost always somewhere in the "Post-Marketing (Early)" row — which is precisely why understanding the stages before and after your own is what makes you promotable rather than just competent at your current task.
Note
At every lifecycle transition — from Phase I to Phase II, from Phase III to regulatory review, from approval to post-marketing — there is a formal handover of safety documentation, an update to the evolving safety database, and a reassessment of the benefit-risk balance. These transitions are high-risk moments for data integrity and documentation completeness. They are a common focus of regulatory inspections.
Quick check
Test yourself before moving on — no pressure, just click an answer.
1. Why are lifecycle transitions (e.g. Phase III to regulatory review) a common focus of regulatory inspections?
2. Which role has cross-functional oversight spanning PSMF maintenance, audits, and CAPA management at the lifecycle maintenance stage?