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Pharmaceuticals, medical devices, cosmetics, and industrial Chemicals, ect has its own unique safety surveillance challenges. Yet, the fundamental goal remains the same: protecting public health through vigilance, risk assessment, and mitigation.
The Challenge:
- Drugs → Complex adverse event reporting, stringent regulatory timelines (FDA, EMA, ICH E2B R3).
- Medical Devices → Device failures, malfunction tracking, patient safety impact (EU MDR, MedWatch).
- Cosmetics → Consumer-reported adverse reactions, ingredient-based safety monitoring.
Let’s break down the key differences in their safety surveillance processes:
Pharmaceuticals: The Gold Standard of Pharmacovigilance
For pharmaceutical products, pharmacovigilance is deeply established with highly regulated case management workflows covering:
✔ Multi-source case intake: Spontaneous reports, safety call centers, EHRs, patient registries, and literature searches.
✔ Structured case processing: Adverse events are coded using MedDRA and WHO Drug dictionaries, and causality is assessed.
✔ Strict reporting timelines: Expedited regulatory submissions (e.g., E2B R3, CIOMS, MedWatch) based on event seriousness and expectedness.
✔ Signal detection & risk management: AI-driven analytics help identify emerging trends in drug safety.
Medical Devices: Beyond Adverse Reactions - Technical Malfunctions Matter
Medical device vigilance expands the scope beyond adverse drug reactions to include device failures, malfunctions, and engineering concerns. Unique requirements include:
✔ Device-specific case intake: Reports from clinicians, manufacturers, device registries, and quality systems.
✔ Technical case processing: Cloudbyz PV integrates engineering assessments, lot numbers, and failure mode analysis into the vigilance workflow.
✔ Regulatory compliance: EU MDR, FDA’s MedWatch, and other global frameworks require detailed device failure reporting.
Cosmetics: Cosmetovigilance and Consumer-Driven Safety Monitoring
Unlike drugs or devices, cosmetovigilance relies heavily on consumer complaints and post-market surveillance. Key differences include:
✔ Consumer-first case intake: Social media, customer service interactions, and online reviews are key data sources.
✔ Trend analysis: Cloudbyz PV enables monitoring of trends in adverse reactions across consumer feedback channels.
✔ Focus on product reformulation: Signal detection identifies potential ingredient risks, supporting proactive changes in formulations.
Cloudbyz PV on Salesforce: A Unified Platform for Multi-Domain Pharmacovigilance
As organizations expand across multiple safety critical product categories, traditional pharmacovigilance systems struggle to accommodate diverse workflows. This is where Cloudbyz PV, built on Salesforce, delivers unparalleled advantages:
Seamless Multi-Source Case Intake
Cloudbyz PV automates case intake from EHRs, regulatory reporting systems, social media, device registries, and environmental monitoring systems—eliminating data silos and ensuring real-time data capture.
Regulatory Compliance Across Industries
Whether it's E2B R3 reporting for pharmaceuticals, EU MDR compliance for devices, voluntary reporting for cosmetics, Cloudbyz PV provides customizable regulatory frameworks.
Customizable Workflows for Different Product Categories
✔ For Pharmaceuticals: Automated medical coding, expedited reporting, and causality assessment tools.
✔ For Medical Devices: Engineering assessment modules, quality system integration, and failure trend analysis.
✔ For Cosmetics: AI-driven consumer complaint monitoring and ingredient-based safety analysis.
✔ For Chemicals: Exposure assessment dashboards, workplace monitoring compliance, and automated safety reporting.
Cloud-Based, Scalable, and Future-Ready
✔ Built on Salesforce’s robust cloud infrastructure, ensuring scalability, security, and seamless global operations.
✔ Mobile-enabled access for real-time case reporting, risk assessment, and decision-making.
✔ AI-driven analytics help companies proactively manage safety concerns before they escalate.
Powered Signal Detection
Advanced analytics detect trends, emerging risks, and potential safety concerns across product categories, improving proactive safety decision-making.
The Future of Pharmacovigilance: A Single Platform for Diverse Safety Monitoring Needs
As regulatory requirements evolve and product categories demand more nuanced, technology-driven safety monitoring, the need for a centralized, configurable, and AI-powered pharmacovigilance system has never been greater.
Cloudbyz PV on Salesforce is leading the way, bridging the gaps between drug safety, device vigilance and cosmetovigilance. With automation, AI-driven analytics, and regulatory compliance at its core, organizations can now seamlessly manage safety workflows across multiple domains within a unified, scalable solution.
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