By Qualification, Dr. Niraj Limbachiya is an MBBS from M.S. University, India. Dr. Niraj has more than 13 years of experience in Global Pharmacovigilance, Clinical Research and Hospital Industry. Prior to joining Lambda, Dr. Niraj was associated with Torrent Pharma as a Global Pharmacovigilance Responsible Person.
In the area of Drug Safety and Global Pharmacovigilance, Dr. Niraj has faced regulatory audits and inspections from Health Authorities of UK-MHRA and Health Canada.
By Qualification, Dr. Naveen Chamalli Shiva Kumar is a physician with a General Management Programme for Healthcare Executives from IIM-B and has more than 12 years of experience in end to end Drug Safety & Global Pharmacovigilance and Clinical Research. Prior to joining Lambda, Dr. Naveen experience includes working in Pharmaceutical companies, Contract Research Organizations including research sites and Business process outsourcing companies like Aurobindo Pharma Ltd, Bluefish Pharmaceutical Pvt Ltd, Quintiles Technologies Pvt Ltd (Now IQVIA), Accenture Service Pvt Ltd, BGS-Global Hospital and Allergy Asthma Associates.
Dr. Naveen C.S. worked as Clinical & Safety Expert in the Clinical trials (Phase I - III) and Post-marketing safety surveillance (Phase-IV) or Pharmacovigilance. In the area of Drug Safety and Global Pharmacovigilance, Dr. Naveen has participated and successfully completed several regulatory audits and inspections from Health Authorities of Sweden-MPA, UK-MHRA, Health Canada, US-FDA, Malta- Medicines Authority, The Netherlands- Medicines Evaluation Board & Portugal- INFARMED.
Agata Gesiewicz is a graduate of the University of College Dublin, where she completed a Bachelor of Science in Pharmacology. She also obtained a Master of Science in Pharmaceutical analysis from Trinity College Dublin. Moreover, Agata completed Postgraduate studies in Medical business management from Warsaw School of Economics and postgraduate studies in Clinical Research Methodology from Medical University of Warsaw.
Agata has more than 7 years in end to end Drug Safety & Global Pharmacovigilance and clinical trial, both in Pharmaceutical companies and Clinical Research Organizations. Her previous experience enable her to focus on achieving a robust Pharmacovigilance system in line with all global requirements. She has an excellent working knowledge of the EU legislation as well as local requirements in the rest of the world. Her gained exposure of Health Authority inspections like Czech Republic-SUKL, Bulgaria-Bulgaria Drug Agency, Latvia-State Agency of Medicines and Lithuania-State Medicines Control Agency have enhanced her understanding for the requirements and increased proficiency to develop robust pharmacovigilance system.