Saurav Bhattacharjee

Background

About Saurav Bhattacharjee

I joined L&T on JUL-2023 as project manager I joined WIPRO in AUGUST 2020 as a B2 manager (medical device complaints) and left WIPRO on 23-AUG-2023. I had joined IQVIA (formerly Quintiles) on December 17, 2012, and worked as a QR certified drug safety scientist and pharmocovigilance systems analyst. Steers Safety Management Team (SMT) for assigned products. Reading pharmacovigilance agreements and clearing knowledge tests regarding the same. Training a team of 6 people and a total of 4 batches, priming them up for production floor. • Quality improvement plan both for pharmacovigilance support team, creating special huddles and projects for the same. Working on a quality improvement project to help with quality improvement in ICSRs. • Time and motion studies. In this, I sat with the incumbent to check the time to perform each field in pharmacovigilance and helping and counseling if required to improve the time. • Worked in pharmacovigilance automation project to check if the system is able to calculate the age and do automatic duplicate search in ArisG. • Significant Contributions • Risk management identification with adverse events serious or nonserious of ICSRs, literature reports, solicited reports, etc. Identifying ICH dates, FDA regulatory submissions • Assessed the risk assessment profile of various drugs with regards to drugs of various multinational companies. • Led discussions with pharmacovigilance physicians regarding attributions and clinical aspects of the cases. • Filed deviations memos regarding processes to the regulatory authorities. • Spearheaded the implementation of Pharmacovigilance profile testing software.