Kelly Catanese
About Kelly Catanese
Kelly Catanese serves as the Director of PV Standards and Training at Insmed Incorporated, bringing over 15 years of experience in Drug Safety and Pharmacovigilance. She has a strong background in handling complex cases and has worked in various roles across multiple organizations in the pharmaceutical industry.
Current Role at Insmed
Kelly Catanese serves as the Director of Pharmacovigilance Standards and Training at Insmed Incorporated. She has held this position since 2021, where she is responsible for overseeing the development and implementation of pharmacovigilance standards and training programs. Her role involves ensuring compliance with regulatory requirements and enhancing the quality of drug safety practices within the organization.
Previous Experience in Drug Safety
Prior to her current role, Kelly Catanese worked at Insmed Incorporated as the Associate Director of Drug Safety and Pharmacovigilance Operations from 2019 to 2021. She also served as a Senior Pharmacovigilance Scientist at Insmed for one year from 2018 to 2019. Her extensive background includes positions at Helsinn Group as Senior Manager of Drug Safety from 2012 to 2018, and at Celgene as a Drug Safety Specialist from 2011 to 2012.
Educational Background
Kelly Catanese earned her Bachelor of Science degree in Registered Nursing from La Salle University, completing her studies from 1998 to 2002. This educational foundation has contributed to her over 15 years of experience in the fields of Drug Safety and Pharmacovigilance.
Expertise in Pharmacovigilance
With over 15 years of experience in Drug Safety and Pharmacovigilance, Kelly Catanese has developed proficiency in handling complex cases, including Serious Unexpected Suspected Adverse Reactions (SUSARs) and Investigator Initiated Trials (IITs). She is skilled in working on aggregate reports such as Development Safety Update Reports (DSUR), Periodic Adverse Drug Experience Reports (PADER), and Periodic Safety Update Reports (PSUR).
Technical Proficiency
Kelly Catanese is proficient in various pharmacovigilance tools, including ArisG, Argus, and MedDRA. Her technical skills support her work in ensuring effective drug safety monitoring and reporting, which are critical in the pharmaceutical industry.