The Pharmacovigilance Podcast

Transforming Benefit-Risk Assessment with AI


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New episode of The Pharmacovigilance Podcast

Guests: Romain Clément and Olivier Merle from ArcaScience

Benefit–risk assessment is at the core of pharmacovigilance. More data, faster development timelines, increasing complexity, and rising expectations from regulators andLeadership is challenging traditional approaches that rely heavily on manual review and retrospective analysis.

In this new episode, we explore how AI is reshaping benefit–risk decision-making and what this means for senior safety professionals today.

Together with experts from ArcaScience, we discuss:

  • What AI actually changes in day-to-day benefit–risk work
  • How integrated data supports earlier and more confidentdecisions
  • How ArcaScience models support benefit–risk acrossdevelopment stages
  • How regulators are reacting to AI-supported approaches

This conversation focuses on practical realities and on how safety teams can use AI to strengthen expertise, not replace it.

🔗 Learn more & connect

ArcaScience website: https://arcascience.ai
Romain Clément on LinkedIn: https://www.linkedin.com/in/romainclement75/

Olivier Merle: https://www.linkedin.com/in/oliviermerle/

ArcaScience on LinkedIn: https://www.linkedin.com/company/arcascience/

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The Pharmacovigilance PodcastBy Julia Appelskog