Sudheendra Rao

About Sudheendra Rao

I am a physician-scientist (MBBS, PhD) with 14 years of post-PhD experience across the drug development lifecycle—from molecular pathogenesis and preclinical R&D to global pharmacovigilance. My core expertise lies in translating complex biological data into actionable clinical safety insights, particularly within Neurology and Rare Diseases. ​In my current role at IQVIA, I provide medical safety oversight for high-stakes clinical assets. I have personally performed the medical review of over ICSRs and managed safety data for large-scale trials involving subjects. Beyond routine operations, I focus on process optimization; I developed a functional AI-driven medical intelligence prototype designed to streamline rare disease literature searches and ground safety queries in authoritative sources like PubMed and FDA labels. ​Core Competencies:​Clinical Safety & Medical Data Review: Expert-level medical review, signal detection, and MedDRA/WHODD coding. ​Clinical Trial Support: Experienced in the development and implementation of Medical Monitoring Plans (MMP) and programmed safety listing reviews. ​Translational Research: Deep background in cellular and molecular biology, including AAV/Lentiviral vector design, CRISPR/Cas9, and GMP-oriented cell therapy development. ​Technical Liaison & Regulatory AdvisoryI have extensive experience acting as a scientific bridge between research entities, regulatory bodies, and clinical practices. My work focuses on ensuring that advanced therapies (like Cell & Gene Therapy) meet both scientific rigor and regulatory compliance standards through active participation in policy drafting, ethics committee leadership, and multi-stakeholder research coordination.​Scientific Communication: Extensive experience in technical writing, having authored peer-reviewed scientific publications and news articles on healthcare policy. ​I am driven by the challenge of solving unmet medical needs through rigorous scientific inquiry and efficient clinical operations.

Experience

1. Senior Medical Safety Advisor

   IQVIA

   Mar 2024 — Present · Bengaluru, IN

   Performing medical review and clarification of post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary/Medical assessment comment as applicable. • Acting as Global Safety Physician/Assistant or Back-up on projects as assigned. • Providing coverage all medical safety deliverables within regulatory or contracted timelines• Maintaining awareness of medical-safety-regulatory industry developments.

Education

• M.M.Arts and Science College, Sirsi, Uttara Kannada, Karnataka

  Preuniversity, Physics, Chemistry, Mathematics and Biology

  1995 — 1997

• Mysore Medical College & Research Institute

  Bachelor of Medicine and Surgery (M.B.B.S), Medicine and Surgery

  1997 — 2003

• University of Miami

  Postdoctoral, Neurotrauma

  2013 — 2018

• Telang High School, Sirsi, Uttara Kannada, Karnataka

  SSLC, General with Sanskrit

  1994 — 1995

• National Brain Research Centre, Gurgaon

  Doctor of Philosophy (Ph.D.), Cellular and Molecular Neuroscience

  2006 — 2012