About
Pharmacovigilance and drug safety professional with hands-on experience in individual case safety report (ICSR) processing, MedDRA and WHO Drug Dictionary coding, and narrative writing. Skilled in data validation, cleaning, and report generation using SAS Enterprise Guide, SAS Studio, and SAS ODS. Experienced with clinical trial data, study protocols, and Statistical Analysis Plans, with a consistent record of regulatory-quality output and Good Clinical Practice compliance. Seeking a data analyst or pharmacovigilance role in the life sciences industry.
Experience2
Junior Data Analyst
Apr 2019 — Jan 2020Sciformix Technologies
Managed drug safety case entry and data processing ensuring accuracy and integrity. Conducted medical coding, narrative writing, and peer review for regulatory submissions. Coordinated case follow-up and maintained data quality checks following SOPs to meet timelines and compliance.
Medical Safety Specialist
May 2017 — Apr 2019Tata Consultancy Services
Entered and verified case data in ARISG database supporting medical review and risk assessment. Performed MedDRA and WHO coding and authored patient narratives. Collaborated with quality teams to process complaint cases and reviewed safety investigations. Represented Global Medical Safety in quality assurance and post-market surveillance, contributing to product risk assessments. Assisted in safety workflow design and was recognized as Star Performer of the Month three times.
Projects2
Source Document Review
Reviewed source documents and queries in IRMS to identify potential cases for reporting, categorized documents as missed adverse events and product complaints, and extracted validated information from source records to support case creation and safety assessments.
- IRMS
Case Processing
Reviewed source documents to identify and report adverse events per SOPs and protocol, structured and entered serious and non-serious adverse events into the safety database, and performed clinical assessments adhering to Good Clinical Practice and regulatory guidance.
- Safety Database
Education4
M.Pharmacy
2016Y.B. Chavan College of Pharmacy, Aurangabad
B.Pharmacy
2014Dayanand College of Pharmacy, Latur
12th Standard
2010Maharashtra State Board
10th Standard
2008Maharashtra State Board