Dipl.Biol., MBA, PMP, PMI-CPMA, MRQA

Stefan Brüning

Co-Founder and Consulting Practice Lead

Building PV systems for whatever situation put them under strain.

Certifications

  • Project Management Professional (PMP)®
  • PMI Certified Professional in Managing AI (PMI-CPMAI)™
  • International Multidisciplinary Change Management IMCM®
  • Professional Scrum Master
  • Professional Scrum Product Owner
  • AI Security & Governance

Stefan Brüning has spent over fifteen years building pharmacovigilance systems, and rebuilding them when circumstances outgrow what is in place. That has meant designing a PV system from nothing as a company approaches its first marketing authorisation. It has meant resizing one after an acquisition doubles the product portfolio overnight. It has meant going in after a failed inspection to fix what the finding exposed. Different starting points, same underlying problem: a system that no longer matches the company running it.

He founded Viginext Advisors Ltd. (formerly Brüning Consulting) to do this work for small and mid-size pharma and biotech companies, drawing on his prior experience at Horizon Therapeutics (now Amgen), PRA Health Sciences (now ICON), and Navitas Life Sciences (formerly WCI).

Stefan holds a Master's degree (Diplom-Biologe) in Molecular Biology from RWTH Aachen University and an MBA from IU International University. He is a certified Project Management Professional (PMP®), Certified Professional in Managing AI (PMI-CPMAI™), and International Multidisciplinary Change Manager (IMCM®).

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