Reinhold Schilling | Schilling Vigilance
Global Pharmacovigilance Leader · EU QPPV · Speaker · Lecturer
Pharmacovigilance that holds up under inspection.
EU QPPV, Stufenplanbeauftragter and Head of Global Pharmacovigilance. Keynotes, training and university teaching on pharmacovigilance systems, inspection readiness and responsible AI, for pharmaceutical teams, conference organisers and academic programmes.
Or email [email protected]Explore the books
Ways to work together
Speaking and training formats
Keynotes
Conference and congress contributions on drug safety, leadership and responsible AI.
Request a keynoteExecutive Workshops
Working sessions with leadership teams on safety governance and decision-making.
Discuss a workshopRegulatory Training
Structured training on pharmacovigilance obligations, QPPV responsibilities and inspection readiness.
Discuss a trainingAcademic Teaching
University and executive education connecting regulatory science with practical safety work.
Discuss teaching
Professional exchange on pharmacovigilance governance, regulatory accountability, leadership and the responsible use of artificial intelligence is also welcome.
Start a professional exchangeAt a glance
A focused overview
Since 2011
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
Global Pharmacovigilance
Safety governance, risk and signal management, quality systems and inspection readiness across international markets.
AI in Pharmacovigilance
Practical implementation of artificial intelligence, automated case processing and responsible human oversight.
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 AI-supported case intake and E2B(R3) data structuring, with defined expert oversight, validation evidence and a documented audit trail. Built around the questions an inspector actually asks: who decided, on what basis, and where is it written down?
- 01AI-supported case intake
- 02AI-supported E2B(R3) data structuring
- 03Expert quality control
- 04Governance and validation
Books
Practical books on pharmacovigilance and the pharmaceutical industry
English · PDF, 431 pages
Practical Pharmacovigilance
From Case Intake to Benefit–Risk Judgement
For the people who do pharmacovigilance work and the people accountable for it.
97 figures · quizzes with explained answers · templates
39 €
Deutsch · PDF, 394 Seiten
Die Pharmaindustrie
Rollen, Übergaben und Entscheidungen verstehen
Für Einsteiger, Quereinsteiger und Wiedereinsteiger in der Pharmaindustrie.
22 Abbildungen · über 160 Glossarbegriffe · Merksätze
19,99 €
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 (in development, German)
- From Science to the Office (in development, German)
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.
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 fifteen years of experience in pharmacovigilance and regulatory affairs.
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
Professional exchange
Speaking. Training. Teaching. Professional exchange.
Enquiries from pharmaceutical organisations, conference organisers, professional associations and academic institutions are welcome.
Prefer to choose the topic first? See all ways to get in touch