Dr. Angelo Seby MD, Macp
About Dr. Angelo Seby MD, Macp
Dr. Angelo Seby is a medical professional specializing in clinical safety and pharmacovigilance. He currently serves as the Director of Clinical Safety and Pharmacovigilance at Ocugen, having previously held positions at Bioclinica and Parexel, among others.
Work at Ocugen
Dr. Angelo Seby serves as the Director of Clinical Safety and Pharmacovigilance at Ocugen since 2022. In this role, he is responsible for overseeing the safety of clinical trials and ensuring compliance with regulatory requirements. His work includes active participation in Data Safety Monitoring Board (DSMB) meetings, where he provides critical safety input. Dr. Seby is currently involved in projects related to Gene Therapy and Covid-19 Vaccine Immunology, contributing to the advancement of innovative therapies.
Previous Experience at Bioclinica
Before joining Ocugen, Dr. Seby worked at Bioclinica as the Medical Director from 2018 to 2022. During his four years in this position, he was instrumental in managing clinical safety protocols and enhancing pharmacovigilance practices. His experience in the Greater New York City Area allowed him to develop a robust understanding of clinical operations within a leading clinical research organization.
Education and Expertise
Dr. Seby holds a Doctor of Medicine (MD) from Odessa National Medical University, completed in 2013. He furthered his education with a Family Medicine Residency Program at the American Academy of Family Physicians from 2017 to 2020. Additionally, he obtained a Post Graduate Diploma in Drug Safety and Pharmacovigilance from Clinosoft Research Institute in 2021. He also achieved a Certificate in Randomized Clinical Trials from Stanford University School of Medicine and is certified in Regulatory Affairs.
Professional Background
Dr. Seby has held various positions in the pharmaceutical and clinical research sectors. He worked as an Associate Director at Parexel from 2016 to 2018 and at Red Nucleus for six months in 2016. His experience includes a role as a Clinical Safety Physician at Pfizer in Delhi, India, from 2014 to 2015. His diverse background spans multiple therapeutic areas, including Oncology, Cardiovascular, Dermatology, Neurology, and more.
Achievements in Pharmacovigilance
Throughout his career, Dr. Seby has authored numerous critical documents in pharmacovigilance, including 53 Development Safety Update Reports (DSURs), 67 Periodic Benefit-Risk Evaluation Reports (PBRERs), and 51 Risk Management Plans (RMPs). He has also developed 25 Risk Evaluation and Mitigation Strategies (REMS) and 35 Standard Operating Procedures (SOPs). His strong understanding of the FDA Orange Book and Purple Book enhances his contributions to drug safety and regulatory compliance.