QPPV & PSMF · Section 11.3
~6 min read · The Drug Safety Coach — Global PV Career Course
Key points
The named-accountable-person requirement, region by region
| Region | Named role | Key characteristics |
|---|---|---|
| EU/EEA | QPPV | Must be EU/EEA resident; personal legal accountability; mandatory deputy arrangement |
| India | PVOIC (Pharmacovigilance Officer-in-Charge) | Introduced under Schedule M; India-resident requirement; a more recently formalised role than the EU’s QPPV |
| United Kingdom | RPPV (post-Brexit UK equivalent) | UK-resident requirement, structurally similar to the EU QPPV but under separate UK-specific regulation since Brexit |
| United States | No single named-person equivalent | PV responsibility is distributed differently — no one FDA-mandated named individual carries the same personal accountability model as QPPV/PVOIC/RPPV |
Full text
The QPPV model Lesson 11.2 described is an EU regulatory design, not a universal pharmacovigilance standard — and understanding how other major regions handle the same underlying question (who, specifically, is accountable for this company’s PV system) is exactly the kind of comparative regulatory fluency this course has built since Module 2.
India’s equivalent is the PVOIC — Pharmacovigilance Officer-in-Charge — introduced under Schedule M as part of India’s ongoing PV regulatory maturation. Like the QPPV, the PVOIC must be India-resident and carries accountability for the company’s PV system within India’s regulatory framework. The role is more recently formalised than the EU’s QPPV, which has existed in something like its current form for considerably longer — a reflection of how India’s PV regulatory infrastructure has been actively developing and tightening in recent years, a theme that connects directly to Module 1’s coverage of India’s PV milestones.
The UK, since formally separating from the EU regulatory framework post-Brexit, maintains its own named-person requirement — commonly referred to as the RPPV — structurally similar in concept to the EU QPPV but governed under distinct UK-specific regulation rather than falling under EU jurisdiction. A company operating in both the EU and the UK post-Brexit needs both a QPPV and a UK-specific equivalent — they are not interchangeable, even though the underlying responsibilities are conceptually similar.
The US stands apart from this pattern entirely: FDA regulation does not mandate a single named individual carrying the same personal, EU-style legal accountability. PV responsibility in the US regulatory framework is distributed differently across a company’s regulatory and safety functions, without a directly equivalent named role. This is a genuine structural difference worth understanding precisely, not glossing over — a candidate who describes the US system as simply "having a QPPV like the EU" is making a factual error that a US-focused interviewer would likely catch immediately.
Quick check
Test yourself before moving on — no pressure, just click an answer.
1. What is the key structural difference between how the EU and the US handle PV accountability?
2. What is India’s equivalent of the EU’s QPPV, and under what regulation was it introduced?