Angelo Seby

About Angelo Seby

Experienced Medical Doctor | MSL | Pharmaceutical Industry Expert | Medical Affairs | Pharmacovigilance | Regulatory Affairs | Clinical Development WHO-Certified | FDA-Experienced | EMA-CertifiedPhysician (MD) with over 11 years of comprehensive experience in the pharmaceutical and healthcare industry. Proven track record across Medical Affairs, Pharmacovigilance, Regulatory Affairs, Clinical Development, and Medical Science Liaison (MSL) functions, contributing to successful global drug development and post-marketing activities. Medical Science Liaison & Medical Affairs Leadership:• Acted as a trusted scientific and clinical expert, building strong relationships with KOLs across multiple therapeutic areas.• Delivered scientific presentations, led advisory board discussions, and supported investigator-initiated studies (IIS).• Provided clinical insights to cross-functional teams in early- and late-stage product development, ensuring alignment between field intelligence and internal strategy.• Supported product launches and lifecycle management through evidence generation, MSL field insights, and real-world data initiatives.• Therapeutic area expertise includes Oncology, Cardiovascular, Neurology, Dermatology, Ophthalmology, Rare Diseases, Autoimmune Disorders, and Orthopaedics. Regulatory & Global Compliance Expertise:• Extensive hands-on experience working with FDA, EMA, Health Canada, and other global regulatory bodies.• Led eCTD submissions, FDA NDAs/ANDAs, EMA ASMF/EDMF filings, and Orphan Drug Designation approvals (US & EU).• Participated in regulatory strategy meetings and authored responses to health authority queries. Pharmacovigilance & Drug Safety:• Expert in ICSR processing, MedDRA coding, causality assessment, aggregate reporting (PBRERs, DSURs, PSURs), REMS, and RMPs.• Authored 53 DSURs, 67 PBRERs, 51 RMPs, 25 REMS, 33 Investigator Brochures, and 35 SOPs.• Supported signal detection, benefit-risk assessment, and global safety surveillance using systems such as Oracle Argus, ArisGlobal, Empirica, and EudraVigilance.• Participated in Data Safety Monitoring Boards (DSMBs) to provide clinical safety input. Certifications & Academic Background:• Certificate in Randomized Clinical Trials – Stanford University School of Medicine• Postgraduate Diploma in Pharmacovigilance and Drug Safety• Diploma in Drug Discovery• Certified in Regulatory Affairs Currently involved in House Calls and CCM.

Experience

1. Director Clinical Safety and Pharmacovigilance

   Ocugen

   Mar 2022 — Present · PA, US

   Pharmacovigilance-Regulatory Affairs-Clinical Development•Application of Medical judgement for the analysis and interpretation of complex clinical safety data for signal detection and initiation of Risk management activities.Prime Focus on Signal Detection,Aggregate Reporting & Risk Management.• Serves as Senior Clinical Safety Representative in the cross-functional teams. Create clinical safety strategy for global projects.• Assure Product Safety compliance to internal and external stakeholders.• Signal detection, Aggregate Reporting (DSUR,PBRER)Risk Management RMP & REMS• Timely and concise response to regulatory agency requests relating to Patient safety.• Assure CAPA’s are implemented effectively• Set safety strategy for IND & NDA filings and initiation of first in human studies.• Oversee all processes that lead to the production of Safety sections of Clinical trial Documents.• Review of AEFI’s Adverse Events following Immunization• Attends regulatory meetings and provide PV Inputs and updates.• Close monitoring of Safety of products, working in line with Clinical Development and Manufacturing Teams.• Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards.• Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication.• Review and contribute to safety relevant SOP and improvement of safety relevant SOPs.• Attends DSMB meetings and provides safety inputs• Provides Safety Updates of Products In pipeline at the Regulatory meetings • Reports to the SVP Regulatory Affairs

Education

• Carmel School Kuwait

  High School Graduate, Science

  2005 — 2007

• American College of Physicians

  MACP

  2016 — 2017

• American Academy of Family Physicians

  Family Medicine Residency Program

  2017 — 2020

• Odessa National Medical University

  Doctor of Medicine (MD), Physician

  2007 — 2013

• Stanford University School of Medicine

  Certificate, Randomized Clinical Trials

  2016 — 2017

• Clinosoft Research Institute

  Post Graduate Diploma, Drug Safety and Pharmacovigilance

  2020 — 2021

• Biopharma Institute , NJ, USA

  GCP-ICH Certificate, Clinical Trials

  2016 — 2017