Piyali Chatterjee

Background

About Piyali Chatterjee

I am working as Medical Safety Expert in Sandoz Patient Safety India (Since 03 Jul 2023). In my present role, I need to support to the Medical Safety Leads (MSL)/Global Program Safety Lead (GPSLs)/ Group Head, Medical Safety Operations according to the needs for delivery activities, i.e. co-authoring safety documents, assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. Provide support to the GPSLs by creating quality deliverables within agreed timeframes and adhering to a high standard of accuracy in compliance with Patient Safety business rules, standard operating procedures and global and local regulatory requirements. Before this, I was working as a Team Leader at Cognizant Life Science Division, Hyderabad (Feb 2016 -Jun 2023). In that role I was performing Qc'r and lead author role of Periodic Safety report (PSUR), Addendum statements, US PSRs, including Periodic Adverse Drug Experience Report (PADER), US supplement to PSURs and Clinical Significance Assessment (CSA) documents and Team Leader/Literature Reviewer/signal detection. In parallel to functional deliverables, I also responsible to provide input to Senior Leadership Team on Service Level Agreements (SLA), calculation and management of Turnaround Time (TAT) score, Quality-checking (RCA/CAPA if needed), Allocation of work and Utilization Report based on deliverables and workload. I was also the key associate for audit, training compliance, customer POC and mentoring (including peer-review) new joiners within my project. Before joining to Cognizant (Feb 2012-Feb 2016), I was in a professional break due to my child's heath issue. During this time, I was conducting a music class at home.Prior to this, I worked as Safety processing Expert at Novartis Healthcare Pvt Ltd for more than 4 years (2007 to 2012). In this role, I facilitated safety monitoring by optimizing scientific quality documentation and data entry of safety case reports for Novartis drugs. I was also responsible for the receipt, tracking and initialization of drug safety reports in to the safety database. Throughout my professional career, I was highly engaged with training and mentoring activity at Novartis and Cognizant, which allowed me for on-boarding and/or transferring knowledge to new joiners to organization and team. Out of my non-project association, I was also leading the cultural team activity where I planned and executes different events as a part of the Associate Engagement Policy.