Gladys Gonzalez
About Gladys Gonzalez
Gladys Gonzalez serves as a Senior Specialist in DSPV Operations at Insmed Incorporated, where she has worked since 2021. She has extensive experience in pharmacovigilance and drug safety, having held various roles at notable companies including Pfizer, Vertex Pharmaceuticals, and Akebia Therapeutics.
Work at Insmed
Gladys Gonzalez serves as a Senior Specialist in DSPV Operations at Insmed Incorporated, a position she has held since 2021. Her role involves managing the weekly and monthly AQL Verification process in collaboration with GMP QA colleagues. She coordinates requests for PSMF updates with Subject Matter Experts, ensuring that all comments are addressed. Insmed is located in Bridgewater, New Jersey, United States.
Previous Experience in DSPV Operations
Prior to her current role, Gladys Gonzalez worked as a DSPV Operations Contractor at Akebia Therapeutics for five months in 2020. She also held the position of Operation Specialist 2 in Life Cycle at IQVIA for six months in 2021. Additionally, she served as a Senior Pharmacovigilance Specialist at Deciphera Pharmaceuticals for four months in 2020, and as a PV Associate III at Vertex Pharmaceuticals from 2018 to 2019.
Education and Expertise
Gladys Gonzalez earned a Bachelor's of Science degree in Health Care Policy and Planning from New York University. Her educational background supports her extensive experience in drug safety and pharmacovigilance, contributing to her expertise in the field.
Career Background in Drug Safety
Gladys Gonzalez has a diverse background in drug safety and pharmacovigilance. She has worked at several notable companies, including Pfizer as a Regulatory Safety Associate from 2001 to 2004, and at Sunovion Pharmaceuticals as a Drug Safety Associate from 2009 to 2011. Her experience also includes roles at Mesoblast Limited, Bayer HealthCare, and Bristol-Myers Squibb, where she contributed to safety data management and clinical safety.
Achievements in Process Improvement
Throughout her career, Gladys Gonzalez has developed processes aimed at enhancing operational efficiency. Notably, she established a monthly E2B submission review meeting process with a vendor to improve submission efficiency. This initiative reflects her commitment to optimizing workflows in drug safety operations.