Dr. Sarala Gudiwada joined ONO PHARMA USA, INC. in March 2021 as the Head and Vice President of Drug Safety and Pharmacovigilance, where she is responsible for leading safety assessments and risk management and safety operations activities of various programs in the U.S. and globally.
Sarala brings over 15 years of experience building and leading teams responsible for signal detection and risk management across clinical and marketed products in various therapeutic areas. She joined ONO PHARMA USA, INC. from Asahi Kasai Pharma America, where she provided Pharmacovigilance leadership to both the US and Japan across the Oncology, Infectious Disease and Pain therapeutic areas. Her prior experience includes progressive drug safety and pharmacovigilance roles at Vertex Pharmaceuticals, Nektar Therapeutics, and Bio Marin Pharmaceuticals.
Sarala earned her MBBS (Bachelor of Medicine and Bachelor of Surgery) at Siddhartha Medical College in India and her MPH from the University of Massachusetts in Amherst, MA. She has experience in providing patient care and she is also certified by the Education Commission for Foreign Medical Graduates, making her eligible for U.S. Board Certification.