Planning for a paradigm shift in the delivery of Pharmacovigilance services, AWINSA Life Sciences provides end-to-end PV services including in its ambit both clinical trial and post-marketing services. Manned by people with discernment and an eye for quality, we at AWINSA Life Sciences ensure astute analysis of safety reports so that clinical scenarios emerge in perspicuity.
Intricate and deep-rooted knowledge of the subject and the international regulations will ensure that you are delivered services of the highest order within the stringent timelines.
Backed by a team of industrious individuals, we aim to provide the highest quality of services to our client. Filled by passion and an indefatigable attitude at AWINSA Life Sciences, we envision unparalleled solutions to all your requirements thus ensuring the safe and efficacious use of drugs for society.
Dr. Sanjeev Miglani, Founder and Director of AWINSA Life Sciences, MD in Internal Medicine, with sharp and active intellect has a rock-solid foundation of academics further heightened by his vast experience in the medical arena. He has over 24 years of experience in Medicine, Pharmacovigilance, and Clinical research. Establishing the correct chain of events is quintessential in safety monitoring and his patient and adroit analysis of the safety reports can unravel the medical situations swiftly and with precision. Keen on spreading the acquired knowledge, he has participated in many international conferences as a speaker. He embarked on his journey in clinical research and Pharmacovigilance as a Senior Manager in Ranbaxy after doing a senior residency in Cardiology and Internal Medicine and then was Director of Medical and Pharmacovigilance at CliniRx, and Chief Operating Officer at CIDP. He moved up on the ladder as VP of Accenture before joining APCER as the Vice president of PV, Clinical Safety North America and Global Medical Affairs.
Dr. Mugdha Chopra, Co-founder and Director of AWINSA Life Sciences, is a woman of great sagacity. She is a Dental Surgeon by qualification with post-graduation in Clinical Research. With over 20 years of experience, and extensive and deep-rooted knowledge of various Pharmacovigilance databases, systems and processes, she can adeptly supplement technology with knowledge. Her vast experience in the implementation of large Pharmacovigilance projects is another feather in her cap. A speaker at various national and international conferences, her presentation skills have been decorated with awards at various international conferences. She began her journey with a successful stint in Ranbaxy where she achieved excellence in management of Pharmacovigilance compliance. Later, she worked as Associate Vice President of Pharmacovigilance and Clinical Safety at APCER.
Dr. Arun Ram is the Medical Director of Pharmacovigilance and Medical Affairs at AWINSA. He is a family physician with advanced training in Clinical Pharmacology and is based in Virginia. Dr. Ram oversees AWINSA's medical affairs and pharmacovigilance activities, which encompass medical reviews across various therapeutic areas, including oncology, respiratory, neurology, cardiology, gastroenterology, and psychiatry. With a distinguished career, Dr. Ram previously served as the Pharmacovigilance Leader for Novartis, Project Head for Pfizer's Drug Safety and Surveillance project in India, and a Senior Research Scientist for Ranbaxy. In addition to his extensive medical background, Dr. Ram recently earned an Executive MBA from Rutgers Business School, further enhancing his leadership and strategic management skills in the healthcare industry.
Wendy Kleijberg, EU QPPV studied Medicine at the Radboud University in Nijmegen and graduated as Master's in medicine. She started her career in the pharmaceutical industry in pharmacovigilance in 2006 as a local safety officer for a medium-sized pharmaceutical company. After two years she continued her career at global pharmacovigilance level and started writing regulatory reports and performing signal detection. Due to a merger, she changed to a generic company and continued her activities globally. After 8 years of PV experience, she started a career as an independent consultant. She has been involved in many projects and PV systems. She is experienced in both local pharmacovigilance activities and global pharmacovigilance activities, from case processing to report writing, from local literature search to signal detection and from SOP writing to MedDRA subject matter expert. She is now acting as EU-QPPV for clients. She is working on various PV-related projects, in line with company and client expectations, including but not limited to LPPV expertise, global and local literature search, regulatory intelligence, case processing, report writing (RMP, PBRER), data analysis and signal detection activities, PV SOP writing, PSMF writing, etc.
Passion and enthusiasm for our work provides us the necessary motivation to move on with grit
Perseverance and commitment to excellence because productivity is never an accident
Aiming for the highest quality in work outputs
Integrity, honesty and transparent working style
Teamwork: Individual efforts directed towards organizational goals in unison always ensure success
Melissa Palmer, MD FAASLD is an internationally renowned Hepatologist and an experienced biotech/pharma executive. She has been in leadership roles at Kadmon (acquired by Sanofi) where she was the Senior Vice President of Pharmacovigilance, Shire, (acquired by Takeda) where she spearheaded the Hepatic Safety Committee, Takeda where she was the Head of Liver disease clinical development and Gannex/Ascletis, where she was Chief Medical Officer. She is currently CEO of Liver Consulting LLC, consulting exclusively to biotech and pharmaceutical companies on Hepatology-related issues such as: innovative trial designs for all liver diseases including metabolic dysfunction-associated steatotic hepatitis (MASH) and primary sclerosing cholangitis (PSC), all aspects of liver disease drug development from pre-IND to NDA, hepatic impairment studies. Dr Palmer’s specific expertise is in hepatic adverse event (HAE) adjudication and hepatic signal evaluation during clinical trials -drug-induced liver injury (DILI), and formation of and chairing hepatic adjudication committees HAC. She has published numerous peer-reviewed guidances and position papers coauthored with colleagues from regulatory agencies on the subject of DILI during clinical trials and is frequently an invited lecturer on this topic at major conferences worldwide.
Arnabh Basu MD is an American Board of Psychiatry and Neurology (ABPN) boarded Geriatric Psychiatrist with many years of clinical and research expertise in neuropsychiatric disorders such as Dementias with Behavioural problems, Schizophrenia, Bipolar Disorder, Major Depression, Anxiety Disorders and ADHD among others. He is a graduate of the University College of Medical Sciences, Delhi University, and completed a Psychiatry residency from Maimonides Medical Center followed by fellowship training in Geriatrics from Columbia University, NY. His research has previously focused on patient safety by reducing the risk of injury in elderly adults with severe Hoarding Disorder and reducing the prescribing of addictive medications such as benzodiazepines and opiates. Dr. Basu is also working to expand the delivery of telepsychiatry to underserved communities. At present, he is the Unit Director of inpatient Psychiatry at Maimonides Medical Center, and Clinical Assistant Professor at SUNY Downstate University.
Dr. Ashok Kumar Vaid is Chairman, the Department of Medical Oncology & Haematology at Medanta Cancer Institute, Medanta-The Medicity, Sector-38, Gurgaon, Haryana, India. Dr. Vaid obtained his MBBS and MD (Internal Medicine) degrees from the University of Jammu, India. He was awarded his Doctor of Medicine (DM) degree in Medical Oncology from the Tamil Nadu Dr. MGR Medical University in Chennai, India in 1993. Before his current appointment, Dr. Vaid practiced and coordinated the Department of Medical Oncology at the Rajiv Gandhi Cancer Institute and Research Centre (RGCI) in Rohini, Delhi, India. In addition to his active medical oncology practice, Dr. Vaid has participated in many national and international clinical trials for finding new cancer treatments. Dr Vaid established bone marrow transplant services in the private sector in Delhi starting with Rajiv Gandhi Cancer Institute & Research Centre during the last decade and has cumulatively carried out the largest number of bone marrow transplants in the private sector in Delhi. Currently, at Medanta he leads a large team which comprises of hemato-oncologists, pediatric transplant specialists, hemato pathologists specializing in transplant pathology, transfusion specialists, and molecular pathologists required for HLA typing and post-transplant chimerism monitoring. Dr. Vaid lectures nationally and internationally and has contributed to numerous peer-reviewed articles, book chapters, and abstracts. His work has appeared in the Journal of Clinical Oncology, Journal of Thoracic Oncology, World Journal of Gastroenterology, and Hepatobiliary Pancreatic Diseases International. Dr. Vaid currently chairs the Indian Council of Medical Research Subcommittee on formulating guidelines for the treatment of Hodgkin's Disease in India. He is recognized as a Teacher and Examiner for the super-speciality course of Medical Oncology by the National Board of Examinations and the Bombay University and a reviewer of thesis for the award of the PhD degree in Life Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, India.
He was conferred the prestigious "Padma Shree" Award, one of the highest civilian awards in India, by the President of India in 2009 for his contribution to the field of medicine on 14th April 2009.
Dr. Samir Kubba, is a dynamic interventional and clinical Cardiologist with more than 20 years of experience in Cardiology. A Gold medalist during his MBBS, he is trained at the prestigious Maulana Azad Medical College, Delhi and PGIMER, Chandigarh. He is amongst the youngest Cardiologists in the country to receive the Fellowship of the American College of Cardiology and the European Society of Cardiology. He was instrumental in initiating and establishing the primary angioplasty programme at Jaswant Rai Superspeciality Hospital, Meerut and Artemis Health Institute, Gurgaon during his prior affiliations. He has also worked with the Metro Group of Hospitals, Delhi and NCR as Senior Interventional Cardiologist. Prior to joining Max Hospital, Patparganj he was Head of Cardiology, Incharge Cath Lab and Academic programme, Narinder Mohan Hospital and Heart Centre, Ghaziabad. He has been an invited faculty at almost all of the reputed national and international Interventional Cardiology conferences where he has presented many complex interventional cases and papers. He was awarded the best complex Interventional Cardiology case award at the TCT India Next conference in 2014 and was an invited Faculty at TCT Washington DC during the same year. His interest lies in Primary and Complex angioplasty, Pacemaker and ICD implantations, Heart failure management, and Clinical Cardiology. He is keenly involved in academics and teaching and has publications in various journals, and online publications, contribution to chapters in the Cath Lab Practicals Book, and is also a part of the Lipid Association of India Expert Panel Consensus Statement Part 2. He is the Vice President of the "Ghaziabad Cardiac Forum", Course Director of the "Cardiology Connect" meeting involving young Interventional Cardiologists, and the "National Coordinator" for the Survey "Primary PCI Registry 2016". He has significantly worked on the role of "Pharmaco-invasive strategy in tier 2 cities of India for STEMI", the paper for which is ready for publication in the Journal of Association of Physicians of India this year. He also received the "Distinguished Service Award" from the Boston Cardiac Foundation for implanting free pacemakers to poor patients for the last 11 years.
Dr. Vibhor Pardasani is a consultant in neurology, trained at AIIMS, New Delhi with more than 20 years of experience in this field. He graduated from Maulana Azad Medical College and completed his MD in Internal Medicine from Lady Hardinge Medical College. He also pursued a post-doctoral fellowship in Refractory epilepsy at King's College London. Besides receiving the best resident award in AIIMS for his unflinching dedication, he was also the recipient of the best poster (2ndprize) at ECON 2009, the 10th annual conference of the Indian epileptic Society, and the Indian Epileptic Association at SVIMS. He has numerous publications in national and international journals to his credit. He worked for three years as an Assistant Professor in the Department of Neurology, IHBAS after completing his Senior Residency in Neurology at AIIMS. He then joined as a consultant Neurologist at Seven Hills Health City before moving to Bombay Hospital Institute of Medical Sciences as a Consultant Neurologist and Epileptologist. Besides the above, he is also providing his services to Wockhardt Hospital, Mumbai Central as an Honorary Neurologist. He is designated as Assistant Professor in Neurology at the Maharashtra Health University.
Dr. Zippee Godha is an experienced gynecologist who pursued her post-graduation (MS) from AMU Aligarh and later on completed her DNB. She completed her Senior residency at DDU Hospital and Indraprastha Apollo Hospital New Delhi before joining as an Assistant Professor at Mahatama Gandhi Hospital and Medical College Jaipur. She is a member of the Federation of Obstetric and Gynaecology society of India. She has several publications in national and international journals to her credit.
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