Catherine Andrus

Catherine Andrus has a diverse work experience in the pharmaceutical and medical device industries. Catherine is currently serving as the Associate Director of Pharmacovigilance Compliance and Training at Calliditas Therapeutics, where they oversee the PV quality system, inspection program, and PV quality risk management. Catherine is responsible for implementing and maintaining effective monitoring and control systems to ensure compliance with regulations.

Prior to their current role, Catherine worked at ProPharma Group as the Pharmacovigilance Quality Assurance Manager. In this position, they provided leadership for quality activities and drove positive change and process improvement in client pharmacovigilance programs. Catherine also managed various quality management processes to maintain quality standards and ensure regulatory compliance.

Before joining ProPharma Group, Catherine served as the Senior Manager of Medical Device Safety at Bayer. Catherine represented PV Medical Device Safety in stand-alone medical device PMS activities and conducted data analysis of information submitted to the FDA to ensure accuracy and integrity. Catherine also fostered strong working partnerships with team peers and stakeholders and was considered a reliable subject matter expert in device safety.

Catherine's earlier work experience includes roles as a Quality Assurance Supervisor and Quality Engineer at Jarvik Heart Incorporated, where they acted as the primary quality interface with manufacturing and production. Catherine also worked as a Validation Engineer at Jewel Precision and as an Office Assistant at Monroe Comprehensive Medical Care.

Overall, Catherine Andrus has demonstrated their expertise in pharmacovigilance, quality assurance, and medical device safety through their various roles in the pharmaceutical and medical industries.

Catherine Andrus holds a Bachelor of Science (BS) degree in Biomedical/Medical Engineering from the New Jersey Institute of Technology. Catherine also obtained a Master of Science (M.S.) degree in the same field of study from the same institution. Additionally, they have completed the Power BI Essential Training certification from LinkedIn in June 2022 and the ISO 13485:2016 Lead Auditor (TPECS) certification from BSI in February 2018.