Dr. Kathrin Wawra-Hehenberger | Safety Risk Management | Best Researcher Award

Senior Director Safety Risk Management Lead at CSL Behring, Germany

Dr. med. Kathrin Wawra-Hehenberger is a distinguished medical doctor and health economist with over 25 years of impactful leadership in the pharmaceutical industry, including nearly two decades focused exclusively on global drug safety. An internationally recognized authority in Safety Risk Management, she has consistently advanced innovation and operational excellence across the full spectrum of the product lifecycle, from early development to postmarketing phases. Her visionary work in translational and clinical safety science has contributed significantly to the evolving regulatory and clinical frameworks, particularly in areas such as gene therapy, coagulation disorders, intensive care, and rare diseases. Dr. Wawra-Hehenberger is widely respected for her pioneering approaches to risk mitigation, strategic oversight of safety programs, and development of innovative safety tools that prioritize patient outcomes and regulatory alignment. A leader known for fostering global collaboration, she integrates medical expertise with strategic insight to elevate patient safety standards and compliance across complex therapeutic areas.

Profile

Orcid

Education

Dr. Wawra-Hehenberger completed her medical degree at the University of Munich between 1990 and 1997, where she also earned her doctorate (“Dr. med.”) in the Department of Infectious Diseases, culminating in 1997. She was licensed in 1998 following clinical rotations in internal medicine, ophthalmology, and surgery across Germany and Chile, with additional internships in Australia and the UK, which enriched her international medical perspective. Her early medical training laid the foundation for her later specialization in pharmacovigilance and safety sciences. Her educational background is complemented by her certification as a Health Economist from EBS, which reinforces her dual focus on clinical excellence and health system efficiency.

Experience

Her professional career began in 1999 with Procter & Gamble Pharmaceuticals, where she served as a Medical Manager in Germany and subsequently as Senior Medical Advisor Europe at the company’s Geneva headquarters. In these roles, she led national quality management projects, launched 100 osteoporosis-focused quality circles, and shaped product messaging, clinical strategies, and regulatory documentation. From 2006 to 2012, she worked at Merck Serono in Geneva, initially as a Senior Medical Information Specialist and later as Director and Associate Director of Global Drug Safety, Risk Management & Epidemiology. During her tenure, she led the harmonization of Risk Management Plans (RMPs) for European marketing authorization holders and contributed expert safety assessments to health authority interactions. In 2013, she joined CSL Behring Innovation GmbH in Marburg, Germany, where she has since held pivotal roles. From 2013 to 2021, she served as Director of Global Clinical Safety & Pharmacovigilance, developing risk management strategies for coagulation, intensive care, cardiovascular, and respiratory indications. She oversaw submissions, safety strategy development, and the implementation of signal detection systems like Empirica Signal. Since January 2022, she has held the role of Senior Director and Global Lead for Safety Risk Management, focusing on process innovation, optimization, and oversight of global risk minimization programs.

Research

Her research interests lie in advancing pharmacovigilance tools, visual risk modeling in early-phase clinical trials, safety strategies for complex therapeutic areas, and process innovation in global safety oversight. She has been instrumental in bridging early clinical insights with long-term patient safety outcomes and has championed safety frameworks that incorporate both data science and clinical relevance. Her work contributes to shaping international regulatory discussions and optimizing health authority responses through evidence-based methodologies.

Awards

Throughout her career, Dr. Wawra-Hehenberger has received multiple invitations to speak at prestigious conferences, highlighting her influence in shaping global pharmacovigilance practices. Her work has earned her acclaim within industry circles for leading transformative risk assessment models and integrating patient safety at the heart of clinical strategy.

Publications

Her published contributions reflect a consistent dedication to both innovation and real-world safety applications. Notable publications include:

1. “A visual safety risk evaluation tool in early clinical phases”, Contemporary Clinical Trials, 2025, [In Press], DOI: https://doi.org/10.1016/j.cct.2025.107953 — cited by 3 articles;

2. “Patient safety with regard to microbiological risks in the manufacture, use and monitoring of sterile medicinal products”, pharmind, 2020 — cited by 7 articles;

3. “Safety of a pasteurized plasma‐derived Factor VIII and von Willebrand factor concentrate: analysis of 33 years of pharmacovigilance data”, Transfusion, 2017; 57:2390–2403 — cited by 21 articles;

4. “Hypoactive sexual desire disorder in postmenopausal women”, Gynecological Endocrinology, 2006; 22(6):318-323 — cited by 12 articles;

5. “New Approach to Simplify Osteoporosis Treatment Regimen for Bisphosphonate and Calcium”, JBMR, 2004; 19(Suppl 1):M424 — cited by 9 articles;

6. “Quality Circles Increase the Quality of Care Osteoporosis Patients in Germany”, JBMR, 2003; 18(Suppl 2):S380 — cited by 5 articles;

7. “Standardized Documentation of Osteoporosis Patients in Germany”, JBMR, 2002; 17(Suppl 1):S466 — cited by 4 articles.

Conclusion

In conclusion, Dr. Kathrin Wawra-Hehenberger represents a rare blend of medical expertise, strategic vision, and international leadership in pharmaceutical safety. Her career is marked by sustained contributions to the development and implementation of cutting-edge safety tools, regulatory guidance, and collaborative innovation across therapeutic domains. Her commitment to patient-centric, data-informed drug safety continues to shape best practices in global pharmacovigilance. As an award nominee, she embodies the highest standards of excellence and dedication in advancing global health through safety innovation.