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Speaker detail

  • Maria D Tello
  • Executive Director of Safety & Pharmacovigilance
  • Rakuten Aspyrian

Maria is a passionate professional and dynamic leader with over 17 years of pharmacovigilance experience in all clinical phases of product development and post marketing. She is known for the ability to create a collaborative environment, deliver, communicate, coach, and lead teams in development. Her key accomplishments in safety science include: representing Safety Science in three NDAs, one with Phase II data; creating the company’s 1st Risk Management Assessment Process prior to EMA’s release of Module XVI; representing Safety Science on the Roche EU PV Legislation Team (2012-2014); creating signal detection training materials and processes for new safety MDs which shorten their learning curve into industry; creating collaborative partnerships between the affiliates and global safety functions; leading the resolution of 23 PRAC questions in the company’s 1st PBRER, as well as launching the Company’s Pregnancy Prevention Electronic Portal change management on how MDs interacted with Roche; developing a program to transition MDs who manage cases to manage signal detection. As Executive Director of Safety & Pharmacovigilance at Rakuten Aspyrian now, Maria is responsible for the strategic global implementation, execution, and management of pharmacovigilance and risk management activities in conjunction with the company’s development and commercial activities, industry standards, and compliance with global regulations. She is also responsible for oversight of CRO safety units. Currently Rakuten Aspyrian has multiple products in development, one in phase III, and Maria is focused on creating and launching the global safety database.