KETAN MARULKAR, Senior Pharmacovigilance Officer, Chanelle Pharma

Pharmacovigilance Physician and QPPV with over 16 years of experience. Over 6 years of medical practice in the fields of endocrinology, cardiovascular disease, obesity, and metabolic syndrome. 10+ years’ experience in end-to-end pharmacovigilance activities including medical review of ICSRs, aggregate reports (PSURs/PBRERs), signal detection and risk management, and continuous benefit risk monitoring of medicinal products (pre- and post-marketing).

Experienced in monitoring and analysing safety data from clinical trials, protocol review, and sponsor oversight of clinical trials. Handled branded and generic portfolios including biologics/biosimilars and vaccines for pharma companies like Novartis, Sandoz, Amgen, Pfizer, AstraZeneca, Viatris and Dr Reddy's Laboratories.