Pharmacovigilance Strategy Expert for Emerging Life Sciences Companies

Stefan Brüning is a specialized pharmacovigilance advisor with over 15 years of strategic experience guiding small to medium-sized pharmaceutical and biotech companies through critical regulatory transitions and operational challenges.

As Founder and Managing Director of Viginext Advisors GmbH, Stefan provides boutique advisory services focused exclusively on pharmacovigilance excellence for organizations with limited internal resources. His expertise spans three critical areas that emerging life sciences companies struggle with most: establishing compliant PV systems, optimizing outsourcing strategies, and implementing effective technology solutions within regulated environments.

Stefan's consultative approach is distinguished by his ability to translate complex regulatory requirements into practical implementation roadmaps tailored to companies at pivotal growth stages—whether transitioning from clinical trials to first marketing authorization, expanding into new markets, or restructuring existing PV operations to improve efficiency.

Prior to founding Viginext, Stefan held leadership positions in pharmacovigilance where he specialized in driving organizational change, developing streamlined processes, and achieving inspection readiness for companies facing regulatory scrutiny. His work has demonstrably helped clients successfully implement EU pharmacovigilance structures, migrate safety databases, and develop multi-market compliance strategies that enable business growth while maintaining regulatory excellence.

Stefan holds a degree in Molecular Biology from RWTH Aachen University and an MBA from IU International University of Applied Sciences. His expertise is further enhanced by certifications in Project Management (PMP®, Scrum) and Change Management (IMCM®), providing a structured methodology for guiding clients through complex regulatory and organizational transformations.