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Virtual

Jun 13, 2023 9:30 AM - Jun 13, 2023 12:30 PM

Signal Management in Pharmacovigilance

Instructors

Himanshu  Bhatnagar, MD

Himanshu Bhatnagar, MD

Associate Medical Director, Parexel International , India

Himanshu Bhatnagar is an Ophthalmic surgeon with over a decade’s clinical experience, and nine years of experience in pharmacovigilance. During these years he has worked extensively in drug safety as a Brand Safety Physician, including activities such as Signal Detection & Management, RMP and IB updates, aggregate reports, Clinical Study Reports, and label updates. He is an SME and is involved in mentoring teams in Signal Management Activities and has created training curricula for people starting out in medical writing roles. He also heads a team of product safety leads working for a major pharmaceutical company.

Vineeta  Malik, MD

Vineeta Malik, MD

Director, Safety Medical Writing, Parexel International , India

Vineeta Malik is a physician (Gynecologist) with over 14 years of experience in pharmacovigilance, including signal detection and management, RMPs, aggregate reports and PV operational management. She has worked as a Safety Scientist/Brand Safety physician for multiple clients, including functioning as a Safety Science leader. She has created and led curriculums for medical writers and safety scientists and also created and run workshops on Risk Management. Currently she is involved in Safety Services Operational and Strategic Management, providing expertise in safety medical writing.

Kausik  Maiti, MD

Kausik Maiti, MD

Executive Director, Safety Medical Sciences, Parexel International , India

Dr. Kausik Maiti is a physician-scientist with over two decades of experience spanning clinical medicine, pharmacovigilance, and regulatory strategy. He leads a global team of 300+ clinicians and safety experts across all therapeutic areas and is a recognized thought leader and speaker at DIA, WDSC, ASCO, ASH, and other global forums. He actively drives AI-enabled transformation initiatives to advance patient-centric, data-driven safety, and signal management.

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