Geeta Shanbhag
Vice President - Pharmacovigilance & Medico-regulatory Affairs @ Ipca Laboratories Limited
About
I have more than two decades of experience in pharmaceutical industry, inclusive of medico-marketing, clinical research, bioequivalence studies, regulatory affairs and pharmacovigilance. I started out my career as trainee in medical documentation in Ipca Laboratories Ltd., wherein I was involved in reference search and handling queries of healthcare professionals. In medico-marketing, I was involved in preparation of product manuals and in training sales representatives on medical aspects of the products. Domestic regulatory affairs then became my main forte as I was prolific with making all type of applications to DCGI/CDSCO right from application for clinical trials to application for manufacturing and marketing a drug with new indication or new strength. In clinical research, I was involved in designing of clinical trial protocols, monitoring of clinical trials along with preparation of clinical study report and publishing it. All activities related to clinical trials for 2 big brands of Ipca, Zerodol and HCQS was done by me. More than 100 bioequivalence studies were coordinated by me, right from review of BE protocol, monitoring of the studies to review of BE report. I have also coordinated Toxicity studies of more than 40 APIs/formulations as per Schedule Y. From past 8 years, I am involved in pharmacovigilance. I have set up Corporate Pharmacovigilance Cell in Ipca, which handles global pharmacovigilance. With more than 70 SOPs in place and good Quality Management System, we now handle pharmacovigilance activities for more than 50 countries. I have hands on training in Aris G database, writing narratives, MedDRA coding, drafting SDEAs, preparing PSURs/PBRERs, RMPs, third party audit.
India
Mumbai
Pharmaceuticals
Pharmaceutical Industry, Pharmacovigilance, Regulatory Affairs, ICH-GCP, SOP, Clinical Trials, Clinical Research, GCP, CRO, Medical Writing, Regulatory Submissions, Management, Life Sciences, Pharmacology, Clinical Development, Aris G, MedDRA, PSURs, PBRER, Risk Management Plans
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