Jaylaxmi Nalawade
Director - Pharmacovigilance and Rems, North America @Lupin Pharmaceuticals
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WORK HISTORY
Director - Pharmacovigilance and Rems, North America @Lupin Pharmaceuticals
New York, NY, US
EDUCATION
Maharashtra University of Health Sciences
Bachelor of Medicine, Bachelor of Surgery - MBBS, Medicine
Haffkine Institute for Training, Research and Testing
Post Graduate Diploma, Clinical Research Management and Regulatory Affairs
ABOUT JAYLAXMI NALAWADE
Experienced pharmacovigilance physician with around 13 years of experience in Pharmacovigilance, Drug Safety, and Risk Management throughout product lifecycle from clinical trials to post marketing in pharmaceutical industry. Global experience working in pharmaceutical industry across different geographies in the US, Europe and India. Presently, medical safety science expert and leader responsible for heading, oversight & management of Drug Safety, Pharmacovigilance and Risk management including REMS for Lupin Inc in North America as Director of Pharmacovigilance & REMS based out of Lupin Somerset, New Jersey, USA. Experience & Expertise: Led various roles within global pharmacovigilance team as medical safety science expert responsible for benefit risk evaluation, signal management, clinical safety, case management, aggregate reports (DSURs, PADERs, PBREBRs, PSURs, AddCo), product risk management and minimization planning, throughout product development process and lifecycle, integration of pharmacovigilance processes, strategic planning in safety data exchange agreements, post authorization safety studies, centralized management of global PV activities, PV quality management system and compliance. Experienced in hosting and supporting regulatory authority PV inspections, PV audits and business partner audits. Active speaker in pharmaceutical and life science conferences on pharmacovigilance-drug safety, safety labeling, product complaints and clinical monitoring. Education: Medical Doctor (MBBS) at Government Medical College, Kolhapur, Maharashtra University of Health Sciences, India Post Graduate Diploma in Clinical Research Management and Regulatory Affairs from Haffkine Institute for Training, Research and Testing, India
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