Global Pharmacovigilance Systems and Governance
Design, oversight and continuous improvement of global pharmacovigilance systems across central functions, affiliates and external partners.
Expertise
Pharmacovigilance expertise built on operational responsibility
Reinhold’s expertise is grounded in senior operational responsibility across pharmacovigilance, regulatory affairs, quality governance and international pharmaceutical operations. His work combines scientific judgement, regulatory accountability, global system oversight and practical leadership in situations where decisions must be clear, documented and defensible.
Clear governance matters most when systems are under pressure and decisions cannot wait.
Areas of expertise
Twelve connected areas of expertise
These areas are closely connected. Effective pharmacovigilance depends on the interaction of governance, scientific assessment, regulatory compliance, quality systems, technology and leadership.
01
Governance and accountability
Oversight structures, regulatory duties, and baseline governance across markets.
EU QPPV Responsibilities
Strategic and practical understanding of EU QPPV responsibilities, oversight duties and organisational positioning.
Pharmacovigilance System Master File
Governance, maintenance and strategic use of the PSMF as an evidence base for effective oversight.
02
Scientific and regulatory decision-making
Applying GVP principles and scientific rigor to risk-benefit evaluations.
GVP and Regulatory Compliance
Translation of Good Pharmacovigilance Practices and international regulatory requirements into sustainable, inspection-ready processes.
Signal Management and Benefit-Risk Evaluation
Governance of signal detection, validation, assessment, escalation and benefit-risk decision-making.
Risk Management
Strategic oversight of pharmacovigilance risk management and the role of risk minimisation in protecting patients.
03
Operations, quality and inspection readiness
Resilient operational workflows, inspection readiness, and safety data integrity.
Audits and Inspection Readiness
Preparation of pharmacovigilance systems, teams and governance structures for audits and regulatory inspections.
Safety Data and Case Management
Oversight of individual case safety reports, data quality, workflows, compliance and operational interfaces.
Literature Monitoring
Regulatory expectations, operating models, quality oversight and the evolving role of technology.
04
Interfaces, technology and leadership
Cross-functional alignment, validated technology adoption, and decision-making under uncertainty.
Interfaces with Quality and Regulatory Affairs
Management of interfaces between Pharmacovigilance, Quality, Regulatory Affairs, Medical Affairs and other business functions.
Artificial Intelligence in Pharmacovigilance
Responsible adoption of AI through governance, human oversight, validation, risk assessment and clear accountability.
Leadership in Regulated Environments
Decision-making, accountability and clear communication in safety-critical and highly regulated organisations.
Perspective
Scientific judgement must be documented and defensible
Regulatory requirements set the floor, not the ambition. A strong safety organisation is distinguished by the quality of its reasoning: whether an assessment can be explained, evidenced and defended years later, and whether the people closest to the data are heard.
This perspective shapes how Reinhold approaches governance, leadership, teaching and writing in pharmacovigilance.
Explain the reasoning
Make the basis for every assessment and decision visible and understandable.
Document the decision
Ensure assessments can be evidenced and defended years after the fact.
Remain accountable
Stand behind the judgement, the process and the people closest to the data.
Application
How this expertise is applied
Training & Speaking
Practical learning formats for pharmacovigilance, governance and leadership in regulated environments.
Learn moreAcademic Teaching
Teaching that connects regulatory foundations with real operational decision-making.
Learn moreBooks & Publications
Writing on pharmacovigilance, management, leadership and responsible use of artificial intelligence.
Learn more
Enquiries
Bring operational pharmacovigilance experience into your programme or discussion
For training, speaking, academic collaboration or professional exchange, please get in touch.