Adverse Events Management

Solution: Managing Adverse Events and FDA Compliance on Social Media

Managing Adverse Events on Social Media for FDA Compliance

A large, global pharmaceutical was concerned that it wasn’t going to stay compliant with the FDA, because it didn’t have the processes in place to properly report, track, and manage its products’ adverse events discussed on social media. LiveWorld partnered with this company to standardize and scale how it managed adverse events on social media so it remains compliant with the FDA.

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Because of its decentralized marketing structure, this leading pharma company faced numerous difficulties staying compliant. Each brand/disease state and global region had its own, siloed marketing efforts with numerous vendors involved. The company had social media efforts popping up globally across these marketing efforts, without a consistent process to track, manage, and report adverse events.

One of the brands was audited by the company’s internal audit team, which found a number of problems with its adverse event monitoring and reporting. This included a lack of social media monitoring coverage on weekends and holidays, using a process that was not well scaled, and using a system that didn’t retain all the right compliance elements.

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LiveWorld was brought in to help the revamp of adverse event management processes so it more closely matched the practices used in other regions/groups. We reviewed six months of social media back data to identify any missed reportables to ensure compliance.

The implemented LiveWorld adverse event/FDA compliance process included:

  • 24x7x365 screening of content by adverse event specialists of content for AEs and escalation and routing in near real time
  • A tailored process that would bring all social content into a single system for identification and reporting of adverse events
  • Comprehensive storage of processes and methods with timelines, including arrival time, time screened, reporting time, and actions taken by Pharmacovigilance team
  • The client was provided with a single social media archive for storage of FDA-compliant source information, such as source location, case and tracking numbers, images, and publishing times

The LiveWorld adverse event specialists worked with the pharma to identify any mention of reactions, efficacy issues, off-label use, product complaints, product quality issues, product questions, and other key issues of interest to the client. Our multi-lingual team was able to monitor social media in numerous languages and dialects in the company’s global regions around the clock.

Once we identified an adverse event, we used our proven process to transfer the critical information to the pharmacovigilance team including providing a case management system to track and then archive for FDA social media compliance.

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The pharma’s internal audit team, which had previously audited LiveWorld, cited LiveWorld as the company best practice and recommended that other departments work with us. Based on the continued success of our FDA-compliant social media solutions the company asked LiveWorld to create a Center of Excellence to outline best practices for adverse event management, global implementation and governance.