Pharmacovigilance & Device Vigilance
We set up and operate safety systems for medicines and medical devices, from clinical trial safety through post-market vigilance. We act as (EU/local) QPPV, manage case processing and signal detection, perform literature reviews, author PSURs and DSURs and RMPs, run device incident reporting and PMS programmes, and handle authority interactions across regions.
Examples of How We Support
These are just examples to illustrate the kind of work we do day to day. The fastest way is usually a short call to understand your situation and discuss how we can help.
Clinical trial safety setup
You are preparing for first-in-human studies and need a clinical trial safety framework. A safety officer, SAE/SUSAR processing, EudraVigilance submissions, and DSUR preparation need to be in place before the first patient is enrolled.
PV system setup
Your product is approaching marketing authorisation and you need a compliant PV system. You need a QPPV or UK NCP appointed, a Pharmacovigilance System Master File and Risk Management Plan built, SOPs written, and Safety Data Exchange Agreements in place with your partners and vendors.
Multi-market PV operations
You have launched in multiple markets and must manage case processing, signal detection, and periodic reporting across jurisdictions. Local safety officers, systematic regulatory authority website screening, harmonised ICSR workflows, literature monitoring, and aggregate reporting (PSURs/PBRERs/PADERs) need to run without gaps.
Device post-market surveillance
Your medical device is on the EU market and you need a PMS system that goes beyond complaint handling. Proactive post-market surveillance, incident trending, PMCF plans, and authority communication need to be structured, documented, and maintained.
PV audit and due diligence
You need an independent assessment of your existing safety systems. GVP audits, vendor qualification, gap analyses, or due diligence evaluations during M&A or licensing transactions.
Understanding Pharmacovigilance & Device Vigilance
Pharmacovigilance and device vigilance share the goal of monitoring product safety after use, but they operate under different regulatory frameworks with different reporting requirements, terminology, and authority expectations.
Pharmacovigilance covers medicinal products: adverse reaction reporting, signal detection, periodic safety reporting (PSURs/PBRERs under ICH E2C(R2)), and risk management under EU GVP and equivalent global frameworks. Device vigilance covers medical devices and IVDs: incident reporting, trend analysis, post-market surveillance plans, and PMCF/PMPF under MDR/IVDR.
We cover both on this page because many clients need both (particularly for combination products), and because the operational infrastructure overlaps: case intake, signal management, authority communication, and periodic reporting all require coordinated systems regardless of product type.
What We Do
We build, operate, and maintain the safety infrastructure and manage the ongoing activities that keep your product compliant across its lifecycle.
Our Workstreams
We organise our pharmacovigilance and device vigilance support into defined workstreams so responsibilities and interfaces are clear.
PV System & Compliance
QPPV/NCP appointment and oversight. Local safety officer networks. PSMF authoring and maintenance. SOP development. Safety Data Exchange Agreements. Quality system audits against GVP. Contractual and subcontractor PV obligations per Implementing Regulation (EU) 2025/1466.
Case Management & Signal Detection
ICSR intake, processing, and submission to EudraVigilance, MHRA, Swissmedic, and other authorities. Signal management per GVP Module IX (updated framework). Systematic medical literature monitoring (MLM): search strategy design, Medline and Embase screening, ICSR identification and triage, compliance with EMA Article 27 monitoring list requirements. Regulatory intelligence monitoring. Safety database hosting, configuration, and operation. Database migration. E2B(R3) compliance for electronic ICSR reporting.
Periodic Reporting & Risk Management
PSUR/PBRER authoring (ICH E2C(R2)) and DSUR preparation (ICH E2F), alongside Risk Management Plans and risk–benefit evaluations, including additional risk minimisation measures (aRMMs). PADER preparation in line with 21 CFR § 314.80(c)(2).
Device Vigilance & PMS
Vigilance quality system setup. Incident reporting and trend analysis per MDR/IVDR. Complaint review and root-cause investigation. PMS plans aligned with MDCG 2025-10. PMCF/PMPF reports. Device PSUR preparation per MDCG 2022-21. Updates to clinical evaluation and risk management documentation.
Clinical Trial Safety
Clinical safety officer and medical monitor services. EudraVigilance responsible person for non-EU sponsors. SAE/SUSAR processing and regulatory reporting. DSUR preparation.
Medical Information
Enquiry handling (telephone, email, webform) for HCPs, patients, and internal stakeholders. Standard response library development and periodic review. Adverse event and product quality complaint identification and triage within MI interactions. MI governance: SOPs, quality controls, documentation standards, reconciliation with safety databases. Enquiry trend monitoring and reporting. Named medical information officer provision.
Audits & Due Diligence
GVP audits and gap analyses. Vendor and CRO qualification for safety activities. Due diligence evaluations of PV and device vigilance systems during M&A or licensing.
PV Training
Bespoke pharmacovigilance training programme design and delivery. GVP Module-by-module training for operational teams and management. Role-specific training for QPPVs, case processors, signal analysts, and safety scientists. Audit and inspection preparation training. Training needs analysis and effectiveness assessment.
Where This Fits in the Development Journey
Safety activities change significantly across the product lifecycle. This overview shows where pharmacovigilance and device vigilance work typically applies.
Discovery & Concept
Outline initial safety profile expectations and PV/PMS planning needs. Support due diligence assessments for in-licensing candidates.
Preclinical
Conduct preliminary safety risk assessments. Design DSUR frameworks. Draft high-level PV system architecture (SOP templates, SDEA strategy) and initial PMS concepts for devices.
Design & Development
Build the safety infrastructure: develop SOPs, SDEAs, and reporting pathways, with full PV system elements (e.g. PSMF, QPPV) established in preparation for regulatory submission.
Clinical & Validation Studies
Operate clinical trial safety: provide safety officers and medical monitors, manage SAE/SUSAR processing and DSUR authoring, oversee EudraVigilance submissions. Start device complaint handling where applicable.
Regulatory Submission & Approval
Compile safety documentation for submissions (e.g. PSMF, RMP), integrate safety data into CTD and TD, and ensure pharmacovigilance and device vigilance systems are inspection-ready. Appoint QPPV and local safety officers, ensuring compliant governance and oversight across jurisdictions.
Launch & Market Access
Transition from clinical safety to active post-market pharmacovigilance. Implement risk minimisation measures and train affiliates. Finalise PMS and PMCF implementation for devices.
Post-Market & Lifecycle Management
Full PV and device vigilance operations: case processing, signal detection and trending, literature and regulatory authority monitoring, PSMF maintenance, PSUR/PBRER/PADER submission, PMS/PMCF reports, clinical evaluation updates, variations, renewals, and GVP audits.
Product Type Considerations
Safety obligations and vigilance workflows differ by product type. These are the key distinctions that shape how we structure our support.
Small Molecules
Established PV processes. Focus on PSUR/PBRER cadence, signal detection from growing post-market exposure, and risk-benefit updates aligned with ICH E2C(R2).
Medical Devices & IVDs
Device incident reporting, PMS plans (aligned with MDCG 2025-10), PMCF/PMPF execution, device PSURs (MDCG 2022-21). Complaints and trends trigger updates to clinical evaluation and technical documentation.
Combination Products
Integrated PV and device vigilance: both ICSR and incident reporting apply, risk management must cover drug and device components, and PSUR and PMCF activities need coordination to avoid gaps or contradictions.
Biologics & ATMPs
Higher vigilance complexity: donor-recipient risks, long-term follow-up requirements, immunogenicity monitoring, and complex safety profiles in DSURs and PSURs. Additionally, increased communication requirements with HCPs and patients.
Digital Health & SaMD
Vigilance must incorporate software anomaly reporting, cybersecurity incident assessment, and real-world performance monitoring. Algorithm updates may require authority notification.
Sample Deliverables
These are examples of what we produce. The scope depends on your product type, development stage, and geographic footprint.
Complete PSMF with QPPV appointment, PV-relevant QMS setup, SDEAs, and inspection-readiness documentation. 
PSUR/PBRER/PADER for a drug marketed in EU, CH, UK, and US, including signal-trend analysis and risk minimisation measures, aligned with updated RMM reporting requirements. 
DSUR for an ATMP clinical trial, meeting ICH E2F requirements and submitted to multiple agencies. 
Incident trend analysis and vigilance report for a Class IIb device, with complaint review, root-cause findings, and authority communication. Post-Market Surveillance Plan and PMCF Report for an implantable device, aligned with MDCG 2025-10 and MDCG 2022-21 expectations. 
GVP audit report with gap analysis and remediation plan, including assessment of subcontractor PV obligations under updated EU requirements. 
Medical information service operational report: enquiry volumes, response timelines, adverse event triage statistics, and trend analysis for a marketed product portfolio. Example Projects
Illustrative Example
Digital Health Company: Rapid PV System Transfer
A fast-growing digital health company appointed a new pharmacovigilance provider as part of a change in PV strategy, requiring a rapid and well-controlled system transfer. We worked closely with internal stakeholders and the outgoing vendor to securely acquire safety data, complete regulatory registrations, and implement a compliant PV framework. The transition was delivered to tight timelines, with minimal operational burden on the client, enabling a smooth move into ongoing PV operations and sustained regulatory compliance.
Illustrative Example
UK-Based Pharmaceutical Company: Full-Service PV Partnership
A UK-based pharmaceutical company required a full-service pharmacovigilance partner to support its ongoing safety obligations. Following a structured selection process, we were appointed to provide QPPV oversight and end-to-end PV services. Our team delivers structured governance, clear oversight of safety activities, and integrated regulatory support, providing the client with confidence that their PV system remains compliant and proportionate to their portfolio.
Setting Up a PV System, Managing Post-Market Safety, or Preparing for an Inspection?
Tell us about your product, your markets, and where you are in the lifecycle, and we’ll outline how we can help.
Speak with a PV ExpertKey Regulations & Guidance
The regulatory framework for pharmacovigilance and device vigilance is evolving. These are some of the documents that frequently shape our work:
Frequently Asked Questions (FAQ)
Do I need a QPPV even if I outsource all PV activities?
Yes. EU law requires a formally appointed QPPV with authority and responsibility over your pharmacovigilance system, regardless of whether activities are outsourced. We serve as QPPV for clients who don’t have or want to maintain the role in-house.
What changed with Implementing Regulation (EU) 2025/1466?
The regulation, fully applicable from 12 February 2026, updates several GVP requirements. Key changes include: MAHs no longer submit standalone signal notifications (signals are managed internally per GVP Module IX); PSURs must include updates on RMM implementation status; and contracts with PV subcontractors must more clearly describe safety data exchange obligations and responsibilities.
How does device vigilance differ from pharmacovigilance?
Pharmacovigilance covers medicinal products and focuses on adverse reactions, signal detection, and periodic benefit-risk reporting under GVP. Device vigilance covers incidents and performance issues with medical devices under MDR/IVDR, requiring complaint trending, PMS plans, PMCF/PMPF activities, and different reporting timelines and authority interfaces.
When should I prepare my PSMF?
Before your marketing application is filed. The PSMF must be in place, reflecting your PV processes, QPPV details, and safety database, and be ready for inspection at the time of submission.
What does MDCG 2025-10 mean for my PMS system?
The December 2025 guidance reinforces that PMS must be proactive and continuous, not just reactive complaint handling. Your PMS plan must define data sources, collection methods, analysis approaches (including statistical trending methodology), and clear links to risk management and clinical evaluation updates. Planning should start during device development, not at market launch.
Do you manage case reporting to multiple authorities simultaneously?
Yes. We handle EudraVigilance submissions and coordinate reporting to MHRA, Swissmedic, FDA, and other authorities through our internal teams and regulanet® members and partners in 90+ countries, ensuring harmonised narratives and consistent timelines.
What if my product is a drug-device combination?
We integrate PV and device vigilance requirements into a single coordinated system. Incidents are categorised correctly across both frameworks, and PSUR and PMCF activities are aligned to avoid contradictions or reporting gaps.
Do you provide medical information services?
Yes. We operate MI services for MAHs as a fully outsourced function or alongside internal teams. Our MI specialists handle enquiries, develop and maintain standard response libraries, triage adverse events and product quality complaints identified during enquiries, and report on enquiry trends. MI and PV are operationally linked: our MI team sits within the same operation as our PV team, with documented processes for forwarding reportable information and reconciling MI and safety databases.
What is signal detection in pharmacovigilance?
Signal detection is the systematic process of identifying new or changing safety issues associated with medicinal products by analysing safety data from multiple sources. It is a continuous activity required under EU GVP Module IX and involves both quantitative statistical methods and qualitative medical evaluation.
What happens after a signal is detected?
Once a potential signal is identified, it must be validated through detailed medical and scientific evaluation. Confirmed signals may lead to further investigation, inclusion in PSURs/PBRERs, updates to risk management plans, product information changes, or regulatory notifications to authorities such as the EMA or MHRA.