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Virtual

13 jun 2023 9:30 a.m. - 13 jun 2023 12:30 p.m.

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

Kausik Maiti is an MD with over 2 decades of experience in Clinical Medicine and Pharmaceutical Industry. Currently, Dr. Maiti leads Safety Physicians, Independent Scientific Data Review Committees, and Signal Management businesses. His team consists of over 300 highly qualified professionals spread across the globe. As part of Global Safety Services leadership, he provides strategic inputs to the business and lead the assigned business functions, client accounts and key initiatives. He provides scientific expertise and contributes to pre-sales activities & PV Consulting. He leads Thought Leadership initiatives for the business unit and drives innovation, research, and technology initiatives in partnership with stakeholders.

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