Instructors
Michelle Geller, MD
Executive Medical Director, Global Patient Safety , Amgen Inc., United States
Dr. Michelle Geller has spent the last 12 years of her career at Amgen, currently as an Executive Medical Director in Global Patient Safety and a Safety Therapeutic Area Head for the Immuno Oncology TA. She has also led various other product and process teams in the Amgen Global Patient Safety function, including the Bone and Cardiovascular Therapeutic Areas, and as the Head of Safety Management including Signal and Risk Management, Safety Governance, Periodic Reports and Medical Review to name a few. Michelle also worked in Scientific Affairs at Novartis as her first Pharmaceutical Industry role. Prior to her roles in Industry, she spent 10 years in Academic Clinical Practice at Mount Sinai and UCLA in Internal Medicine and Women's Health.
Anju Garg, MD
Safety Analyses Innovation and Submission Readiness Lead, Sanofi, United States
Anju has been in the pharmaceutical Industry for over 15 years. After appointments at UCB and Schering Plough, Anju joined Sanofi in 2005. Her career has been predominantly in pharmacovigilance as a Safety Officer at the affiliate and global level. She has gained experience in all aspects of post marketing and clinical trial safety.
Frances McNierney, MBA
Project Manager (Contractor), TransCelerate BioPharma Inc. , United States
Frances has 9 years of experience in strategic project and change management, product launch, and innovation in the life science industry. After being on the supplier side of the pharmaceutical industry, Frances began working with TransCelerate BioPharma Inc. in 2019. Having managed workstreams focused on common fields for Serious Adverse Event (SAE) reporting, patient-level data privacy, and ambiguous clinical trial regulations, she now supports Transcelerate’s Interpretation of Pharmacovigilance Guidances & Regulations work.
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