Anu Rita Jayaraman

Background

About Anu Rita Jayaraman

As the country head of Pharmacovigilance in Eli Lilly Japan, I lead a team of more than 70 colleagues handling safety of products under development and marketed products portfolio, across therapeutic areas, end to end from ICSR, regulatory reports to PMDA, post marketing safety studies in Japan, Japan specific RMP and label, across therapeutic areas. Holding the position of Anseki/ Responsible person for safety management/ Japan QPPV. Worked as Global Safety Physician in Eli Lilly India, holding responsibility for the safety profile of psychiatry, pain and neuroscience (dementia) portfolio molecules with strong expertise in signal detection activities, routine surveillance activities, literature review, PBRERs, PADERs, Addendum reports, HHEs, NDA Annual Reports, REMS Assessment Reports, REMS program oversight, additional risk minimisation activities, responses to Health Authority queries, development and updates of safety sections of Core Data Sheets, USPI, SmPC and country specific labels, Clinical Safety Summary, other submission documents, etc. Expert in development pipeline with regards to big dataset/ trend analysis, visualisation tools, TFL review, and protocol development. In the past, worked as Medical Data Review Manager, delivering responsibilities as a Functional Lead and SME for Neuroscience division of Medical data review in the Global Medical & Scientific Services, Data Science- Safety and Regulatory Unit at IQVIA. I have worked on phase 1- 4 clinical trials as the molecule responsible physician for pipeline molecules for various sponsors, covering end to end trial activities like protocol/ ICF development and amendment, eCRF development, trend analysis with regards to safety concerns, efficacy analysis for primary and secondary endpoints, data analysis for data locks, TFL reviews, IB updates, CSR preparation, etc for indications like schizophrenia, organic psychosis, depression including treatment resistant depression and special populations like pediatric and elderly age groups, dementia, sleep disorder, multiple sclerosis, autistic disorder, ADHD, Parkinson’s disease, and also in post marketed products. I have over 15 years experience post my under graduation, including psychiatry clinical practice, academia as professor of psychiatry and clinical research in pharmaceutical sector.