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GVP Module IX Compliant Signal Management Systems in Pharmacovigilance: A Tale of Two Experiences

Speakers

Christopher  Flood, BSN, MBA

Christopher Flood, BSN, MBA

Senior Director Safety Operations, Erasca, United States

Neal  Grabowski, MBA, MS

Neal Grabowski, MBA, MS

TransCelerate IAO Workstream Lead; Head, Signal Management, Sanofi, United States

Neal is the Head of Signal Management at Sanofi responsible for processes and systems enabling product safety oversight. Prior to joining Sanofi, Neal held multiple roles in Patient Safety and Clinical Operations at AbbVie, Amgen, and Genzyme. He holds a BS in mechanical engineering, MS in biomedical engineering and MBA.

Sadiqa  Mian, MD, MPH

Sadiqa Mian, MD, MPH

Executive Medical Director, Head Safety Management, Amgen Inc., United States

Sadiqa Mian MD MPH currently works as an Executive Medical Director, heading Safety Management Team in Global Patient Safety Department at Amgen. Her current areas of responsibilities include Signal and Benefit Risk Management, Medical Review and Aggregate Reports. She has been at Amgen for 4 and half years. Prior to Amgen, her industry experience includes working at Geznyme, Sanofi and Boston Scientific.

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