Tatiana Drewiacki serves as the Risk-Based Quality Management (RBQM) Coordinator at Galderma, where she plays a pivotal role in ensuring the integrity and safety of clinical research processes. Her expertise in risk management and clinical research is complemented by her dynamic approach to collaboration, particularly...
Tatiana Drewiacki serves as the Risk-Based Quality Management (RBQM) Coordinator at Galderma, where she plays a pivotal role in ensuring the integrity and safety of clinical research processes. Her expertise in risk management and clinical research is complemented by her dynamic approach to collaboration, particularly in working with medical experts on safety and medical listings review. Tatiana's responsibilities include elaborating on queries within Electronic Data Capture (EDC) systems and developing comprehensive medical presentations that highlight interim analyses of studies.
In her role, Tatiana is instrumental in maintaining a competitive intelligence landscape, which is crucial for identifying emerging trends and potential risks in drug safety and clinical trials. She is dedicated to enhancing inspection readiness by meticulously reviewing and updating the medical monitoring guidance document, ensuring that all protocols align with regulatory standards. Additionally, Tatiana manages the preparation of periodic benefit-risk evaluation reports (PBRERs), which are vital for assessing the ongoing safety and efficacy of pharmaceutical products.
Her diverse skill set, which encompasses pharmaceutics, biotechnology, and occupational health, allows her to navigate the complexities of drug safety and clinical research effectively. Tatiana’s commitment to teamwork and her ability to adapt to new challenges—such as relocating to the U.S. and raising bilingual children—reflect her resilience and determination. This unique blend of personal and professional experiences enriches her contributions to Galderma, making her a valuable asset in the field of clinical research and risk management.
