Summary
As patients increasingly share health experiences online, companies must detect and report Adverse Events (AEs), At-Risk Scenarios (ARS), Unexpected Therapeutic Effects (UTEs), Medical Device Complaints (MDCs), and Product Quality Complaints (PQCs) to comply with global regulatory requirements. RILA ensures end-to-end pharmacovigilance compliance through a robust, SOP-driven process that leverages AI for signal detection, multilingual digital monitoring, timely reporting, and strict adherence to data privacy laws like HIPAA and GDPR. Their services offer life science companies a reliable, scalable solution for maintaining regulatory compliance and safeguarding patient safety in the digital age.
Adverse Event & Product Safety Reporting: Ensuring Compliance in the Digital Age
In today’s hyper-connected digital world, patients and healthcare professionals openly share experiences online — from which medications or medical devices they use, to how those treatments or tools affect them. Whether it’s a tweet about a rash, a TikTok describing unexpected relief, or a Facebook post about a defective inhaler — these conversations often contain Product Safety Information that must be captured and reported.
At RILA GLOBAL CONSULTING, we help pharmaceutical and medical device companies stay ahead of regulatory requirements with accurate, timely, and compliant reporting — not just for Adverse Events (AEs), but for a broader range of safety indicators, including:
- Unexpected Therapeutic Effects (UTEs)
- Medical Device Complaints (MDCs)
- Product Quality Complaints (PQCs)
To ensure complete compliance, RILA follows a detailed Standard Operating Procedure (SOP) that defines the process for identifying, reporting, and logging all Product Safety Information. This SOP aligns with Good Pharmacovigilance Practices (GVP) and ensures full regulatory adherence — from detection to documentation.
Why Monitoring Product Safety Information on Social Media Matters
Global health authorities like the FDA, EMA, and MHRA mandate that marketing authorization holders monitor digital channels for reportable safety information. These aren’t just guidelines — they are regulatory expectations rooted in patient safety and risk mitigation.
Modern patients are more digitally active than ever, and the risk of missing a critical safety signal — whether it's a faulty device, off-label use, or medication misuse — increases without proper monitoring of digital and social channels.
How RILA GLOBAL CONSULTING Ensures Full Pharmacovigilance Compliance
Our digital pharmacovigilance solutions are built for accuracy, speed, and auditability. Here’s how we manage the end-to-end process:
✅ Coverage of All Safety Types
We monitor, identify, and escalate a comprehensive set of Product Safety Information:
- AEs – Any undesirable experiences linked to drug or device use
- ARS – Risk-prone behavior or discussions about inappropriate use
- UTEs – Surprising or unintended therapeutic outcomes
- MDCs – Faulty devices or concerns shared by patients or caregivers
- PQCs – Concerns about product defects, tampering, or packaging
✅ SOP-Driven, Audit-Ready Workflows
Our team operates under a robust SOP that governs every step — from signal detection using AI and Boolean queries, to event validation, anonymization, classification, and reporting. Every logged event meets regulatory and legal standards, with clear traceability and documentation for audits or inspections.
✅ Timely Reporting That Meets Regulatory Expectations
Time-sensitive events are processed and escalated rapidly, ensuring submission of valid Individual Case Safety Reports (ICSRs) and other documentation within mandatory timelines.
Global Digital Monitoring — Comprehensive, Multilingual, and Platform-Agnostic
Our multilingual analysts monitor every major digital channel and publicly available website, including:
- Reddit, X (Twitter), TikTok, Facebook, Instagram, YouTube
- Patient forums and online support groups
- Blogs, product reviews, and regional discussion boards
We don’t just track mentions — we extract meaningful safety insights tailored to your product portfolio.
Data Privacy, HIPAA & GDPR Compliance — Built Into Every Step
At RILA GLOBAL CONSULTING, data protection and regulatory compliance go hand-in-hand with our pharmacovigilance services. As we monitor social media and publicly available websites for Product Safety Information, we ensure that all activities are conducted in full alignment with global data privacy laws, including:
- HIPAA (Health Insurance Portability and Accountability Act) — protecting personal health information (PHI) in the United States
- GDPR (General Data Protection Regulation) — safeguarding personal data for individuals across the European Union and EEA
- Local data protection regulations applicable to markets like the UK, LATAM, MENA, and APAC
IT Security & Infrastructure Designed for Compliance
Our IT infrastructure is built with enterprise-grade security protocols to ensure secure data handling, anonymization, and full auditability — all aligned with industry best practices and our internal compliance standards.
Why Choose RILA for Digital Pharmacovigilance?
With AI-powered analytics, real-time monitoring, and pharmacovigilance-trained analysts, RILA delivers end-to-end compliance and peace of mind for life science companies worldwide.
By partnering with RILA, you gain:
- Full compliance with GVP and global regulatory guidelines
- Real-time alerts for all relevant safety information
- Scalable workflows across brands and regions
- A committed team backed by a bulletproof SOP
Ready to Elevate Your Safety Monitoring?
Patient safety and product trust begin with listening.
Let RILA GLOBAL CONSULTING help you lead with confidence in a digital-first world.
Schedule a demo today!
