Marlene Fehling

Marlene Fehling currently serves as the Head of Corporate Drug Safety Systems at Biotest AG, where she leverages over two decades of expertise in computer system validation and data integrity within GxP environments. In this strategic role, she oversees the global master safety database, ensuring its seamless operation, compliance, and integration across diverse markets. Her responsibilities encompass the implementation of innovative safety systems, requirement engineering, and the validation of computer systems to uphold the highest standards of data integrity and regulatory compliance. Marlene’s deep understanding of pharmacovigilance processes and clinical study data management enables her to develop robust procedures that support the integrity and security of sensitive safety data, aligning with industry regulations and quality management systems.

Her extensive management experience, gained through more than ten years of leading cross-functional teams at international headquarters, allows her to effectively coordinate complex projects involving requirements engineering, system validation, and GxP-compliant quality management. Marlene’s expertise in pharma industry standards, combined with her skills in SAS programming and data analysis, positions her as a key driver in optimizing safety data workflows and ensuring compliance with global regulatory expectations. Her strategic initiatives often focus on enhancing data integrity, streamlining validation processes, and integrating new technologies to improve pharmacovigilance systems. With her comprehensive knowledge of computervalidierung, requirements engineering, and quality management, Marlene Fehling continues to contribute significantly to the advancement of drug safety systems at Biotest AG, supporting the company’s commitment to patient safety and regulatory excellence.