Heikendorf, Schleswig-Holstein, Germany
Who I Am and What Makes Me Special in My Job I am a seasoned physician specializing in pharmacovigilance and drug safety with over two decades of experience spanning the pharmaceutical and biotech industries. With a strong foundation in clinical medicine and a deep understanding of regulatory and safety requirements, I bring a comprehensive, pragmatic, and solution-driven approach to ensuring the safe development of therapeutics across all phases of clinical trials. What distinguishes me is my versatility and adaptability: I have successfully led and supported global safety efforts in both large pharmaceutical companies and agile biotech environments. From pivotal oncology studies and pandemic-related vaccine development to setting up entire pharmacovigilance systems for marketing authorization holders, my track record demonstrates a rare breadth of hands-on expertise. Throughout my career, I have consistently taken on complex roles—often during transitional or high-stakes phases of drug development—where I’ve been trusted to provide not only expert safety oversight but also cross-functional leadership. My ability to synthesize clinical insight with regulatory rigor allows me to contribute strategically to risk management, signal detection, safety governance, and regulatory submissions such as DSURs, PSURs, and RMPs. Colleagues value my reliability, calm under pressure, and the clarity with which I communicate medical and safety issues to diverse stakeholders. Whether leading safety strategy for a global team or supporting the launch of first-in-class therapies, I bring dedication, depth of knowledge, and a clear focus on patient safety.
Managing Drug Safety for clinical trials.
Setup and conduct of a pivotal Phase III study in close collaboration with Clinical Development. Establishing a PV system for a Marketing Authorisation Holder including a quality management system, risk management, signal detection, and PV vendor management.
Preparation of IND application, COVID-19 risk assessment, Review of Risk Management Plan, PBRER, DSUR and Manuscripts, Approval of IST`s and Compassionate Use Requests.