Monisha S.
About Monisha S.
Monisha S. is an Associate Director, Pharmacovigilance Scientist at Bristol Myers Squibb, with extensive experience in safety science and trial safety surveillance.
Company
Monisha S. is currently employed at Bristol Myers Squibb as an Associate Director, Pharmacovigilance Scientist. Bristol Myers Squibb is a global biopharmaceutical company known for its innovative medicines. Monisha contributes to the safety aspects of clinical trials and early development in cell therapy and Hematology-Oncology.
Title
Monisha S. holds the position of Associate Director, Pharmacovigilance Scientist. In this role, she oversees the safety surveillance and risk management of clinical trial assets, ensuring compliance with regulatory requirements and maintaining patient safety.
Education and Expertise
Monisha S. achieved a Master of Business Administration (MBA) with a focus on Health/Health Care Administration/Management from Goldey-Beacom College, completed in 2018. She holds a Master of Science (MS) in Pharmacology and Toxicology from Long Island University, completed in 2013, and a Bachelor's degree in Pharmacy from Rajiv Gandhi University of Health Sciences, completed in 2010. Her expertise spans pharmacovigilance, trial safety surveillance, and risk management.
Background
Monisha S. has extensive experience in the field of drug safety and trial safety surveillance. She worked at Celgene as a Senior Manager, Safety Science, before joining Bristol Myers Squibb. Monisha also held various roles at inVentiv Health, including Senior Manager and Manager positions in Trial Safety Science, contributing to Celgene Corporation's projects. Additionally, she served as a Drug Safety Coordinator at Sterile Specialities India Pvt. Ltd.
Achievements
Monisha S. has been responsible for the safety aspects of First-In-Human (FIH) trial initiation for five early development assets in cell therapy (CAR Ts) and one Antibody-Drug Conjugate (ADC) in Hematology-Oncology. She serves as a Subject Matter Expert (SME) on trial safety surveillance and integration activities. Monisha works closely with safety physicians to assess the benefit-risk profiles for assigned assets, manages routine and ad-hoc signal detection, and oversees Safety Data Review Meetings (SDRMs) and Safety Management Team (SMT) meetings.