Reinhold Schilling | Schilling Vigilance
Global Pharmacovigilance Leader · EU QPPV · Speaker · Lecturer
Pharmacovigilance expertise when it matters most.
Working at the intersection of patient safety, regulatory responsibility, technology and leadership to help safety systems remain resilient, compliant and inspection-ready.
At a glance
A focused overview
10+ years
Pharmacovigilance & drug safety
Global PV Leadership
Head of Global Pharmacovigilance since 2021
EU QPPV
Global safety accountability
Stufenplanbeauftragter
Statutory pharmacovigilance responsibility in Germany
International Speaker
Conferences and professional forums
Academic Lecturer
Pharmacovigilance and regulatory affairs
Areas of expertise
Three strategic pillars
01
Global Pharmacovigilance
Safety governance, risk and signal management, quality systems and inspection readiness across international markets.
02
AI in Pharmacovigilance
Practical implementation of artificial intelligence, automated case processing and responsible human oversight.
03
Training & Education
Translating complex regulatory requirements and scientific judgement into clear, actionable frameworks for teams and executives.
Artificial intelligence & drug safety
Responsible AI for structured pharmacovigilance case processing.
AI can support the process. Qualified experts remain accountable.
A Human-in-the-Loop framework for exploring how AI may support case intake and structured data generation while maintaining expert oversight, validation, auditability and regulatory accountability.
- 01AI-supported case intake
- 02AI-supported E2B(R3) data structuring
- 03Expert quality control
- 04Governance and validation
Executive education & events
Speaking and training formats
Keynotes
Conference and congress contributions on drug safety, leadership and responsible AI.
Executive Workshops
Working sessions with leadership teams on safety governance and decision-making.
Regulatory Training
Structured training on pharmacovigilance obligations, QPPV responsibilities and inspection readiness.
Academic Teaching
University and executive education connecting regulatory science with practical safety work.
Higher education
Connecting regulatory science with practical reality
Reinhold teaches pharmacovigilance and regulatory affairs at Goethe Business School (Goethe University Frankfurt) and Reutlingen University, combining a scientific foundation with the perspective of global pharmacovigilance responsibility.
Thematic focus
Selected subjects
- Pharmacovigilance Systems
- EU QPPV Responsibilities
- Signal & Risk Management
- Global Safety Governance
- Inspection Readiness
- AI in Pharmacovigilance
- Human in the Loop
- E2B(R3) & Case Processing
- Leadership in Regulated Organisations
Profile
Grounding leadership in science and practice
Reinhold Schilling is an experienced pharmacovigilance leader, EU Qualified Person for Pharmacovigilance and Stufenplanbeauftragter. His professional background combines a German university degree in chemistry from the University of Bonn with a Master of Drug Regulatory Affairs and more than a decade of experience in pharmacovigilance and regulatory affairs
Publications & writing
Perspectives on safety, technology and leadership
Current publications and book projects address pharmacovigilance, leadership in regulated organisations and the responsible use of artificial intelligence.
- Leadership in the Age of AI
- From Science to the Office
- A Practical Guide to Pharmacovigilance
Professional exchange
Speaking. Training. Teaching. Professional exchange.
Enquiries from pharmaceutical organisations, conference organisers, professional associations and academic institutions are welcome.