DH

Dr. Christina Holfelder

Associate Director, Global Patient Safety (gps) Operations Lead For Clinical Development at MorphoSys

Dr. Christina Holfelder has a diverse work experience in the field of pharmacovigilance and patient safety. Dr. Christina currently serves as the Associate Director and Global Patient Safety (GPS) Operations Lead for Clinical Development at MorphoSys since December 2021. In this role, they are responsible for conducting clinical safety management activities, acting as the primary contact for PV vendors, CROs, and clinical trial teams, and ensuring consistent PV standards and processes across clinical development programs.

Prior to joining MorphoSys, Dr. Holfelder worked as the Senior Manager GPS Operations at the same company from March 2021 to November 2022. Dr. Christina was responsible for defining key performance indicators and metrics, managing compliance, developing training material, and ensuring inspection readiness.

Before their roles at MorphoSys, Dr. Holfelder worked as a Senior Pharmacovigilance Manager at Bavarian Nordic GmbH from May 2020 to October 2020. Dr. Christina also gained extensive experience at Glenmark Arzneimittel GmbH, where they held the position of Senior Pharmacovigilance Manager, Stufenplanbeauftragter/GPO, EU QPPV Deputy from July 2015 to April 2020. In this role, they acted as the EU QPPV Deputy and played a key role in setting up and maintaining the PV and Med Info system in Germany and the EU.

Dr. Holfelder's work experience also includes a role as a Medical Manager Healthcare Services at inVentiv Medical Communications GmbH in 2015, and as a Safety Specialist and Global Safety Lead at INC Research from September 2010 to December 2014. Dr. Christina was responsible for coordinating and leading safety teams in international clinical studies, improving safety-related processes, and communicating with clients, authorities, and investigators.

Dr. Holfelder began their career with research positions at the Max-Planck-Institute, where they completed their PhD thesis from January 2006 to April 2010 and their Diplomarbeit from October 2004 to November 2005. Dr. Christina also received further training in clinical research at the mibeg-Institut Medizin in 2010.

Overall, Dr. Christina Holfelder has a strong background in pharmacovigilance and patient safety, with experience in various aspects of safety management, compliance, vendor management, and coordination of international clinical studies.

Dr. Christina Holfelder's education history begins with their attendance at Berufsoberschule from 1998 to 2000, where they pursued a degree in the social branch and completed their Abitur. Dr. Christina then went on to study Biology at Universität from 2000 to 2005, earning a Diplom degree in General Biology.

In addition to their formal education, Dr. Holfelder has obtained various certifications. Dr. Christina completed courses such as "Outlook: Automating Your Email with Mail Rules" and "Teams aufbauen und führen" at LinkedIn in 2022, as well as "Virtuelle Teams führen" in 2015. Dr. Christina also completed courses in Power BI Desktop, relational database table design, Microsoft Planner, PowerPoint presentation techniques, SQL for non-programmers, effective email writing, Microsoft Teams usage, data visualization and presentation, the fundamentals of Six Sigma, time management with Outlook, and strategic thinking and acting for leaders. These certifications were obtained between 2021 and 2022 through LinkedIn.

Links


Timeline

  • Associate Director, Global Patient Safety (gps) Operations Lead For Clinical Development

    December, 2022 - present

  • Senior Manager GPS Global Patient Safety Operations

    March, 2021