Streamlining Pharmacovigilance: Technology and Use Cases

Learn how AI and automation improve safety workflows with real-world applications.

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Key Use Cases in Pharmacovigilance Optimization

The rapid rise of artificial intelligence presents an opportunity for effective and transformative applications in pharmacovigilance. Intake, query routing and response, case reporting, HAQs, and more are now extremely feasible use cases that create exponential efficiency in reducing costs, administrative burden, and timelines while increasing quality and, most importantly, improving safety.

Reporting Adverse Events

Automating the triage and translation of adverse event reports significantly reduces processing time by over 35%, ensuring compliance with strict regulatory deadlines. AI streamlines case routing, redaction, and machine translation (MT), allowing safety teams to address global cases in real time, enhance patient safety, and safeguard reputation.

Traditionally a manual process, adverse event reporting must be completed within 15 days of submission, often in multiple languages. Automation ensures timely and accurate processing, providing English translations as required for regulatory compliance.

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Patient Queries

AI-powered chatbots and FAQ sections streamline responses to patient inquiries, reducing wait times and administrative workload. Machine-translated templates ensure accessible, region-specific information, supporting product commercialization in global markets.

As healthcare becomes more transparent, patients increasingly take ownership of their health data, directly contacting sponsors, exploring patient programs, and researching products beyond their local markets.

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Contact Centers

Contact centers play a vital role in reporting adverse events, providing patients and caregivers with accessible, multilingual support around the clock. Accurate written feedback from these interactions ensures compliance with regulatory requirements and facilitates precise case triage.

Real-time multilingual translation during follow-ups enhances accuracy, reduces localization costs, and ensures 100% regulatory compliance, prioritizing patient safety and streamlined operations.

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Health Authority Queries

Health authority queries (HAQs) often delay approval timelines as sponsors sift through vast clinical trial documentation to respond. Using natural language processing (NLP), sponsors can quickly extract relevant data from source files, expediting query resolution.

HAQs cover a range of topics, from manufacturing processes to clinical study outcomes, and must be addressed under tight deadlines. Streamlining responses with NLP minimizes delays and accelerates product approvals and launches.

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Data Auto-Labeling

Sponsors accumulate vast amounts of unstructured data from studies, product launches, and patient interactions. Manual labeling is time-consuming and error-prone, leading to inefficiencies and potential quality issues.

Automated, HIPAA-compliant data labeling ensures accurate annotations across audio, video, image, and text, enabling scalability and faster timelines. This accuracy is crucial for meeting launch deadlines and safeguarding patient safety.

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Top Benefits of Smarter Pharmacovigilance

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  • 35% Faster Case Processing

    Automation reduces adverse event case processing time by over 35%.

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  • 24/7 Multilingual Support

    Real-time multilingual contact centers enhance patient safety and reduce localization costs.

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  • Streamlined Data Annotation

    Accurate auto-labeling ensures scalability and accelerates product launches.

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  • Chatbots for Patient Support

    Instant, multilingual responses to patient queries, improving engagement and reducing wait times.

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  • NLP for Document Analysis

    Extracts insights from unstructured documents, expediting health authority query responses and decision-making.

    Conclusion: Shaping the Future of Pharmacovigilance with AI

    AI is no longer a question of feasibility in pharmacovigilance—it is the future of drug safety and efficacy. Leading sponsors are already leveraging AI to address key use cases and exploring new opportunities to enhance reliability and outcomes.

    Human-in-the-loop solutions remain critical to ensure compliance and quality, highlighting the need for a balanced strategy. By combining the right technologies with human oversight, organizations can unlock AI’s full potential and redefine drug safety standards.

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    Explore Our Full Interactive Guide to AI in Pharmacovigilance

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    Dive into practical guidance for choosing the right AI and automation tools to optimize pharmacovigilance workflows. Learn how to evaluate solutions that fit your organization’s unique needs.
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