Susovita Khuntia
Drug Safety Associate
Pune
Summary
A highly motivated Drug safety associate in Pharmacovigilance, driving digital transformation in drug safety with automation. Passionate about bridging the gap between Life Sciences and Technology, I leverage my expertise in ICSR case processing, process automation, and data-driven decision-making to improve patient safety. Always eager to learn and adapt, I thrive in dynamic environments where innovation meets industry expertise! Experienced with pharmacovigilance processes and adverse event reporting, ensuring regulatory compliance and patient safety. Utilizes strong analytical skills and detailed-oriented approach to identify and mitigate potential drug risks effectively. Knowledge of industry regulations and risk management practices, contributing to safer pharmaceutical outcomes.
Overview
8
8
years of professional experience
6
6
years of post-secondary education
3
3
Certifications
Work History
Drug Safety Associate
Tata Consultancy Services (TCS)
Pune
08.2021 - Current
- Acted as a subject matter expert (SME) in pharmacovigilance
- Evaluated and tested AI-based tools for ICSR case processing.
- Overall in Charge of day-to-day case processing activity including SLA monitoring and compliance focus on quality.
- Connect with team members, addressing issues, and update the team with any recent developments.
- Maintaining, monitoring and tracking records relating to training, productivity compliance and quality of the team.
Senior Drug Safety Associate
Bioclinica India Pvt. Limited
Mysore
07.2019 - 08.2021
- Processed and reviewed Individual Case Safety Reports (ICSRs) using ARISg 6.5
- Data entry of ICSRs, generated from different sources (post marketing survey, clinical trial, Regulatory authority, literature and spontaneous) following the criteria set by the client
- Ensured compliance with global regulatory requirements through quality assessments.
Junior Data Analyst
Cognizant Technology Solutions India Private Limited
Kolkata
05.2017 - 07.2019
- Worked extensively on Argus 8.1.2 for adverse event reporting and case processing
- Performed data validation and medical coding using MedDRA and WHO Drug Dictionary.
- Book in of incoming reports for completeness, legibility, and validity. Performed data entry of individual case safety reports into database.
- Peer review of post marketing survey, regulatory authority, clinical trials, literature, and spontaneous cases. Provide the feedback to the data entry team members for the errors noted.
Education
M. Pharm - Pharmaceutics
Gayatri College of Pharmacy
Odisha, India 05.2013 - 07.2015
B. Pharm -
Gayatri College of Pharmacy
Odisha, India 06.2009 - 06.2013
Skills
Pharmacovigilance Database Experience: Argus Safety, ARISg
Digital Transformation in LSH Industry
Automation & AI Applications in Drug Safety
Medical Coding & Safety Narrative Writing
Strong Knowledge of ICSR Processing
undefinedCertification
Skill Enhancement Program, Cognizant Academy, 2017
Digital Initiative Projects
- Automation of Adverse Event Reporting
- AI-Assisted Literature Screening
- Compliance & Regulatory Automation
- AI Chatbot for Pharmacovigilance Queries
Desired Job Position
Digital Healthcare Consultant
Timeline
Drug Safety Associate
Tata Consultancy Services (TCS)
08.2021 - Current
Senior Drug Safety Associate
Bioclinica India Pvt. Limited
07.2019 - 08.2021
Junior Data Analyst
Cognizant Technology Solutions India Private Limited
05.2017 - 07.2019
M. Pharm - Pharmaceutics
Gayatri College of Pharmacy
05.2013 - 07.2015
B. Pharm -
Gayatri College of Pharmacy
06.2009 - 06.2013
Skill Enhancement Program, Cognizant Academy, 2017
Fundamentals of AI in Healthcare, Ongoing
Digital Transformation in Life Sciences, Planned
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