Post-marketing pharmacovigilance
Safeguarding patients beyond approval
Safety monitoring of drugs and medical devices does not end with approval; in fact, approval marks the beginning of a critical new phase of post-marketing. Once products reach the market, they are used by broad patient populations under real-world conditions, which can give rise to the emergence of new, or previously undetected safety concerns.
-
1,400+
global PV professionals -
24/7
support -
500,000+
cases
ICON understands the importance of post-marketing pharmacovigilance. Our dedicated global team manages the safety of products post-launch in the market, covering end-to-end pharmacovigilance services in the post-marketing setting including drug and medical device case processing, signal detection, literature search and review, safety writing, EU QPPV, LPPV, PSMF management, risk management support and safety regulatory intelligence consulting. We deliver thorough, accurate and timely case management to ensure patient safety and regulatory compliance worldwide.
A commitment to excellence
Our rigorous systems and established processes ensure accuracy, consistency and compliance, providing cost-effective, high-quality pharmacovigilance solutions. We focus on:
- Comprehensive adverse event documentation
- Accurate MedDRA and WHO Drug coding
- Regulatory compliance to mitigate risks
- Technology integration for enhanced efficiency and real-time reporting
Driving efficiency with innovation
ICON leverages advanced technology to optimise post-marketing case processing and pharmacovigilance.
Automated data capture to reduce manual errors
AI and machine learning for signal detection and risk assessment
Real-time compliance monitoring
Cloud-based solutions for global collaboration
Integrated reporting tools for dynamic safety data visualisation
Enhanced data security
Post-marketing pharmacovigilance solutions
We provide comprehensive post-marketing pharmacovigilance solutions to safeguard patient safety and maintain regulatory compliance. Our experts deliver the following services, ensuring full oversight of your product’s benefit–risk profile throughout its lifecycle.
Case processing support
ICON provides comprehensive case processing support across the full safety data lifecycle, including the collection of adverse events, triage and prioritisation, causality assessment, medical coding, determination of seriousness and reportability, query management, and reconciliation with partners.
Literature services and social media monitoring
ICON delivers comprehensive literature surveillance, including customised search strategies for post marketing reports, routine pharmacovigilance, signal detection, benefit risk evaluations and risk management plans. We also support systematic and targeted reviews as well as meta-analysis. ICON manages EMA Medical Literature Monitoring by screening and assessing adverse reactions within EudraVigilance and conducts ongoing reviews of local health authority websites to identify emerging safety information.
Safety Surveillance and signal management
ICON’s Safety Surveillance team uses SIGNET to identify potential safety signals, assess emerging trends, and monitor adverse events of special interest. SIGNET’s interactive visualisations enable fast, clear exploration of complex datasets, with configurable views tailored to specific client needs.
Pharmacovigilance System Master File (PSMF) services
ICON develops and maintains the Pharmacovigilance System Master File on behalf of the marketing authorisation holder, including any required local PSMFs, for products marketed when requested (including the EU).
Risk Management and Risk Evaluation and Mitigation Strategy (REMS) Solutions
ICON applies risk management across the full product life cycle, providing global expertise to meet regulatory requirements and tailor strategies to each client. Support includes defining safety concerns and risk minimisation approaches, developing Risk Management Plans (RMPs), REMS and supporting documents, adapting strategies for local submissions, designing post marketing activities, creating additional risk minimisation measures, monitoring commitments, and evaluating effectiveness to update plans as needed.
- 100+ RMP programmes supported
- 40+ programmes with additional risk minimisation measures implemented
Aggregate report writing and publishing
ICON provides end-to-end development and publication of aggregate safety reports, including PBRERs and PSURs, ACOs, local regulatory reports, IND Annual Reports, DSURs and PADERs. With global coverage and strong regulatory insight across key markets, we ensure every report is accurate, compliant and aligned with current international requirements.
EU/UK QPPV and local affiliate services
ICON’s well-established framework provides EU QPPV and LPPV services with exemplary quality and compliance metrics, assuming QPPV/LPPV responsibilities in 80+ countries.
Safety reporting
ICON’s Safety Reporting Group is a dedicated global team with deep expertise in post-marketing safety reporting. This team specialises in end-to-end ICH E2B (R3) regulatory submissions across complex regulatory landscapes, including China, Japan, South Korea, and all European Economic Area countries.
PV regulatory intelligence
ICON’s Pharmacovigilance Intelligence team is a dedicated, multidisciplinary group of associates, specialists, and managers delivering robust identification, analysis, and verification of pharmacovigilance intelligence to support compliant safety services.
Medical information call center services
ICON provides end-to-end medical information solutions for your product as it enters the marketplace and transitions through the product lifecycle. We can support with specialty expertise in pharmaceuticals, biologics, medical devices, OTC products, natural health products and drug/device combinations.
Support on your terms
ICON’s post-marketing pharmacovigilance team supports pharmaceutical, biotech and medical device organisations of all sizes and across all therapeutic areas. Services can be delivered as consulting, standalone, FSP, blended or full service and across all therapeutic areas.
