Pharmacovigilance system design and build
End-to-end design and build of the safety system: operating model, SOPs, workflows, roles, and supporting technology, from case intake through to reporting and audit.
All practices
Pharmacovigilance & Postmarketing Surveillance
A pharmacovigilance system that holds up under inspection, reports on time, and turns safety data into decisions that stand. MRC designs, runs, and remediates drug-safety systems across the EU, UK, and US, from a single engagement to a fully outsourced function.
What we do
MRC helps pharmaceutical and biotech companies run compliant, inspection-ready pharmacovigilance, from a single engagement to a complete outsourced safety function.
QPPV and PSMF
EU and UK Qualified Person Responsible for Pharmacovigilance (QPPV) provision and support, and authoring and maintenance of the Pharmacovigilance System Master File (PSMF).
Audits
Independent audits of the pharmacovigilance system, and of vendors, contract research organisations (CROs), and affiliates, with gap analysis and corrective action (CAPA) management that stands up to scrutiny.
CRO and vendor oversight
For organisations that outsource pharmacovigilance, independent oversight and analysis of CRO and vendor performance against contract, service levels, and regulatory obligations.
Case processing and aggregate reporting
Individual case intake, assessment, MedDRA coding, and electronic submission, together with periodic and aggregate safety reports (PSURs, PBRERs, and PADERs) and expedited reports.
Signal and risk management
Signal detection, validation, and assessment, Risk Management Plans, and risk-minimisation measures with effectiveness review.
Interim and outsourced pharmacovigilance
Interim QPPV and pharmacovigilance cover, or a fully outsourced safety function, scaled to your product, markets, and stage.
Safety data analytics
Routine safety data becomes decisions that stand up to scrutiny. We build analytics around each product and its data, tuned to the questions a safety team and an inspector actually ask.
- Custom to every company and every product: built around your data sources, your therapeutic area, and the questions you need answered.
- Signal analytics, aggregate and trend review, disproportionality analysis, and safety KPIs.
- Dashboards that surface the product's safety profile and the health of the PV system for management and inspectors alike.
- AI-assisted, and developed in line with the EU AI Act and applicable data-protection law, keeping the models that support safety decisions governed and defensible.
Pharmacovigilance inspection readiness
Authorities inspect more often, and increasingly by remote and hybrid methods. We prepare the system, the people, and the Pharmacovigilance System Master File to the point where an inspection is a formality rather than a fire drill.
PV system audit and gap analysis
An independent audit against EU GVP, the UK HMR 2012, and 21 CFR, delivered as a prioritised, CAPA-ready findings report.
Mock inspections
A realistic EMA, MHRA, or FDA mock inspection: document requests, staff interviews, and a mock inspection report or Form FDA 483.
PSMF and documentation readiness
Review and remediation of the Pharmacovigilance System Master File and the records an inspector asks for first.
Remote and hybrid preparation
Platform set-up, document-sharing, and interview rehearsal for the remote inspections authorities now favour.
Interview coaching
Preparing the QPPV and safety team for the questions they will be asked, and how to answer them.
Findings and CAPA response
Drafting and managing responses to inspection findings and 483 observations, with corrective actions that hold.
Where pharmacovigilance systems fail inspection
The same weaknesses recur across postmarketing safety systems, and each is examined at inspection. We find and remediate them before an authority does, as part of our audit and inspection-readiness work.
Safety-data outputs that cannot be analysed
We remediate line-listing and export quality, returning signal detection and aggregate reporting to data that can be worked.
Inconsistent listedness against the reference safety information
We review listedness assessments and resolve the conflicting determinations that drive expedited reportability.
Submission trackers that cannot evidence timeliness
We rebuild the submission record to make planned dates, actual dates, and any lateness independently verifiable.
Late 15-day expedited reports
We map the reporting clocks and fix the process that lets serious, unexpected cases run late.
Vendor or CRO oversight that gives no real assurance
We build the oversight, key performance indicators, and reconciliation that keep delegated work accountable to the marketing authorisation holder.
A PSMF that no longer reflects practice
We bring the Pharmacovigilance System Master File back into line with how the system actually runs.
From first approval to multi-region scale
We scale support from interim QPPV cover and a single periodic report through to building a complete, multi-region safety system.
Emerging biotech
Preparing for first approval and launch, and standing up a PV function for the first time.
Established pharma
Expanding into new regions and extending an existing safety system across borders.
Safety functions in transition
Strengthening, remediating, or outsourcing an existing PV function under pressure.
Compliant on paper, and defensible under PV inspection
Hands-on regulatory experience, applied with a compliance-first mindset, keeps a pharmacovigilance system defensible in front of an EMA, MHRA, or FDA inspector. Every recommendation is mapped to the controlling regulation and sized to the product and the resources behind it.
Every recommendation traced to its rule
GVP module, CFR citation, or ICH reference: never advice without a source.
Sized to your stage
Interim cover, a single report, or a full multi-region build, scoped to your resources.
Built for the inspection ahead
Mock inspections and 483-response strategy drawing on direct health-authority experience.
Standards we work to
EU GVP
Reg (EC) 726/2004 · Dir 2001/83/EC
UK HMR 2012
Human Medicines Regulations · MHRA
21 CFR 314.80
US postmarketing safety · 314.81
ICH E2B / E2C
E2B(R3) ICSRs · E2C(R2) PSUR
Frequently asked questions
What do EMA, MHRA, and FDA each expect in a pharmacovigilance inspection?
Each authority inspects the same core system against its own rulebook, and all three build on the international ICH standards. The EMA and national competent authorities assess conformance with Good Pharmacovigilance Practices (GVP) and the Pharmacovigilance System Master File. The MHRA applies the Human Medicines Regulations 2012 and UK GVP guidance. The FDA inspects the postmarketing safety system under 21 CFR 314.80 and 314.81. Underneath the regional rules sit the ICH E2 standards, which harmonise how safety data is defined, transmitted, and reported: E2D for postmarketing expedited-reporting definitions, E2B(R3) for the electronic format of individual case safety reports, and E2C(R2) for periodic benefit-risk reporting. A system ready for one authority is not automatically ready for another, because the regional obligations, documentation, and timelines differ.
How do remote and hybrid pharmacovigilance inspections work?
Authorities increasingly inspect remotely or in hybrid form, requesting documents through a secure platform and interviewing the Qualified Person and safety team by video. Preparation differs from an on-site inspection: document indexing, platform access, controlled screen-sharing of the safety database, and interview rehearsal each require attention in advance.
When are periodic safety reports due?
Timing depends on the product and the market. In the US, periodic (PADER) reports are due quarterly for the first three years after approval, and annually thereafter. In the EU and UK, the periodic report follows the ICH E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) format, on the schedule set by the Union reference date list or the marketing authorisation. Expedited 15-day reports run against a separate clock and are transmitted as ICH E2B(R3) individual case safety reports. A submission schedule mapped to each product and market is the foundation of timeliness.
Do I need a QPPV and a PSMF?
A marketing authorisation holder in the EU or UK must appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) and maintain a Pharmacovigilance System Master File (PSMF). The QPPV is a named, accountable individual responsible for the safety system; the PSMF is the single document that describes it. Both are examined early in an inspection. MRC provides QPPV cover, and authors and maintains the PSMF, for holders that do not carry the role in-house.
We outsource pharmacovigilance to a CRO. Are we still responsible?
Yes. The obligations under 21 CFR 314.80(b) and under EU and UK law remain with the marketing authorisation holder and are not discharged by delegation. The holder must be able to demonstrate oversight of the delegated activities: defined service levels, monitored key performance indicators, reconciliation, and evidence that issues are escalated and resolved. MRC builds and operates that oversight where the activity sits with a CRO.
How quickly can you provide interim QPPV or pharmacovigilance cover?
MRC provides interim QPPV and pharmacovigilance cover at short notice, taking over an existing function or standing one up from the beginning, scaled to the product, the markets, and the stage of the organisation.
Reviewed September 2026. Practice lead: Scott McCulloch.
Discuss a product, a programme, or an upcoming inspection
Whether you are standing up a pharmacovigilance system, preparing for an EMA, MHRA, or FDA inspection, or strengthening an existing safety function, tell us where you are and we will come back to you promptly.