Jaylaxmi Nalawade | Associate Director
Lupin Pharmaceuticals

Jaylaxmi Nalawade, Associate Director, Lupin Pharmaceuticals

Jaylaxmi Nalawade, is passionate leader in the pharmaceutical and healthcare industry with 11+ years of experience focusing on drug safety, risk management and drug development lifecycle. She is a Medical Doctor and along with a certification in Post Graduate Diploma in Clinical Research Management and Regulatory Affairs involved in Drug Safety and Risk Management activities. She currently leads the oversight and management of Pharmacovigilance and Risk Evaluation and Mitigation Strategies (REMS) for Lupin in North America, namely, the United States and Canada as an Associate Director of Pharmacovigilance and REMS, based out of the Lupin Inc. office in New Jersey, USA. In her current role she is responsible for ensuring safety of the products (drugs, devices, combination products) throughout the development and post marketing stages. She manages REMS activities for several programs including existing ones and development of new programs. She ensures compliance with the regulatory requirements for Pharmacovigilance and Risk Management for company products in North America. Her experience as a physician is well applied in patient safety, drug safety and risk management activities. She has hands-on experience in centralized management of global pharmacovigilance activities, risk management, medical information and medical research in new drug development. She has led various roles within global pharmacovigilance team from safety expert responsible for evaluating emerging safety concerns and risk/benefit profile, medical advisor in case management, medical writing/ aggregate reports, leading product risk management planning team, executing and leading PV-risk based strategies throughout the drug development process and lifecycle, leading integration of regional subsidiaries, led team handling PV compliance and quality systems, safety experts responsible for REMS, vendor management. She is experienced in leading several pharmacovigilance initiatives within cross-functional processes and teams including regulatory affairs, marketing, business development, quality assurance, compliance, R&D and new product launch teams globally. She is experienced in hosting and supporting regulatory inspections and business partner audits. Has thorough knowledge of Pharmacovigilance principles and regulations including CFR, FDA regulations, Health Canada regulations, ICH guidelines, REMS regulations, and EMA’s Good Pharmacovigilance Practices. Her passion for patient safety, drug safety, medical research and leadership energies her to speak in various pharmaceutical and life science industry congresses, conferences, on pharmacovigilance, REMS, audits and inspections, product complaints, safety labeling and clinical monitoring, sharing experiences and learnings. Prior to joining Lupin in 2012, she worked as an Assistant Manager in Medical Affairs at Unichem Laboratories (Mumbai, India) and as a Medical Reviewer in Pharmacovigilance group at Tata Consultancy Services (Navi Mumbai, India). She studied medicine at Government Medical College, Kolhapur, Maharashtra University of Health Sciences, India. She has completed Post Graduate Diploma in Clinical Research Management and Regulatory Affairs from Haffkine Institute for Training, Research and Testing, India.

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