PharmaRevix delivers fully compliant pharmacovigilance and materiovigilance services for medicines and medical devices. From PV system setup and 24/7 QPPV cover to ICSR processing, aggregate reports, signal management, and risk management plans — we help you build and run safety systems that hold up to inspection and protect patients.
Pharmacovigilance is the science and practice of monitoring the safety of medicines after they are marketed — detecting, assessing, and preventing adverse drug reactions. Services typically include case processing (ICSR), aggregate safety reports (PSUR, PBRER), signal management, risk management plans, and a Qualified Person for Pharmacovigilance (QPPV) for EU/UK markets.
A QPPV (Qualified Person responsible for Pharmacovigilance) is the EU- and UK-mandated individual accountable for a company's pharmacovigilance system. PharmaRevix provides 24/7 QPPV and Deputy QPPV cover, including PSMF maintenance and inspection support.
A PSMF (Pharmacovigilance System Master File) is the mandatory document describing a company's pharmacovigilance system in the EU and UK. It covers organization, processes, databases, and quality management. PharmaRevix authors and maintains PSMFs and supports inspection readiness.
Establish your PV system, appoint QPPV, and build or audit your PSMF.
Capture ICSRs from all sources, assess seriousness, and determine expectedness.
Run signal detection, benefit–risk evaluation, and RMP updates as needed.
Submit ICSRs, PSURs, and PADERs; keep PSMF current; manage inspections.
PSUR vs PBRER: PBRER is the ICH E2C(R2) format used in EU, UK, US (where accepted), and other ICH regions. PADER is the FDA-specific US format. PharmaRevix authors all three formats to authority standards.
"Materiovigilance: for medical device and IVD manufacturers, we extend the same safety discipline — post-market surveillance, vigilance reporting, FSCA/FSN coordination, and integration with MDR/IVDR and UKCA requirements."
What is materiovigilance? Materiovigilance is the post-market surveillance system for medical devices and IVDs — monitoring, reporting, and managing safety incidents and field safety corrective actions (FSCAs). PharmaRevix provides materiovigilance support aligned with EU MDR, IVDR, UKCA, and FDA requirements.
Explore Materiovigilance ServicesWhether you're a virtual pharma company needing a full PV system build or a global manufacturer requiring QPPV backup — we adapt to your scale, modality, and geography.
QPPV and Deputy QPPV availability around the clock — across UK, EU, and beyond. No gaps, no missed expedited deadlines.
Every deliverable is built to survive MHRA, EMA, and FDA inspection scrutiny — not just to satisfy internal sign-off.
Whether you have 10 cases a year or 10,000 — we design PV systems that scale with your portfolio and reporting obligations.
Tight coordination between PV and regulatory affairs — no handoff gaps between the team that manages your safety and the one that manages your submissions.
PV doesn't operate in isolation — pair it with regulatory and quality for full compliance cover.
Regulatory strategy, eCTD publishing, marketing authorizations, authority meetings, and lifecycle management.
Explore RA servicesSOP development, GAP analysis, internal PV audits, and inspection readiness across regulatory and quality operations.
Explore QMS servicesDedicated signal detection, evaluation, and benefit–risk assessment aligned with GVP Module IX and EMA PRAC expectations.
Explore Signal ManagementQuick answers to what teams typically ask before engaging us. Don't see your question? Reach out directly.
Ask us anythingA Qualified Person for Pharmacovigilance (QPPV) is a legally required role for all EU and UK marketing authorisation holders. They are responsible for the overall pharmacovigilance system, oversight of safety data, timely submissions, and authority interactions. PharmaRevix provides named EU QPPV, UK QPPV, and deputy cover — so you are always compliant, even during holidays or staff changes.
The Pharmacovigilance System Master File (PSMF) is the core document describing your PV system — including the QPPV, databases, SOPs, contracts, and audit history. It must be kept current and made available to authorities on request within 7 days. PharmaRevix maintains your PSMF on an ongoing basis, updating it whenever systems, personnel, or product portfolios change.
Serious unexpected adverse reactions must be reported within 15 calendar days of becoming aware (7 days for fatal/life-threatening cases in the EU). Non-serious ICSRs are submitted within 90 days. PharmaRevix operates a triage workflow that captures and codes cases from day one of receipt, ensuring deadlines are never missed — including follow-up case submissions.
Yes. PharmaRevix provides end-to-end materiovigilance support for medical devices and IVDs — covering post-market surveillance, serious incident reporting, FSCA/FSN coordination, and MDR/IVDR compliance. This service is available standalone or as part of a combined PV and regulatory package.
Yes. We have a structured handover process covering PSMF transfer, database migration, case backlog review, and QPPV transfer notification to authorities. Most transitions complete within 4–8 weeks. If your current PV system has gaps, we perform a gap assessment first and remediate before formally assuming responsibility.
Book a free 30-minute call with a senior PV team member. We'll listen, ask the right questions, and tell you what's realistic — no commitment required.
