Pratibha Dherange
Pune
Summary
Experienced Pharmacovigilance professional with 6+ years in drug safety and medical device complaint handling. Proficient in ICSR case processing, regulatory compliance, and safety data review using Argus, MedDRA, and Rave. Focused on ensuring patient safety and data integrity in both clinical and post-marketing settings.
Overview
7
7
years of professional experience
Work History
Senior Safety Associate – Pharmacovigilance
Tata Consultancy Services
Pune
06.2021 - Current
- Perform end-to-end case processing of Individual Case Safety Reports (ICSRs) from various sources (clinical trials, spontaneous, literature, etc.) using Argus Safety.
- Conduct medical and scientific evaluation of adverse event reports in compliance with global regulatory requirements.
- Perform triage, data entry, MedDRA coding, narrative writing, and assessment of seriousness, expectedness, and causality.
- Ensure timely and high-quality case submissions to regulatory authorities and partners within agreed timelines.
- Perform quality control (QC) of ICSRs to ensure compliance and data integrity.
- Utilize tools like Argus, MedDRA, Rave, and MS Office for case documentation and data analysis.
- Support mentoring of junior team members and participate in knowledge-sharing initiatives.
Junior Data Analyst – Device Complaints
Cognizant Technology Solutions
Pune
05.2018 - 05.2021
- - Handled medical device complaint data, assisting in identifying trends, reporting nonconformities, and updating regulatory reports.
- - Gained exposure to regulatory compliance related to ISO standards and FDA MDR for medical devices.
- - Supported root cause analysis and coordinated with quality teams for CAPA planning.
Education
Master’s - Pharmacy
SP Pune University
01.2019
Skills
- ICSR Case Processing (Clinical & Post-Marketing)
- Regulatory Compliance (FDA, EMA, CDSCO, MHRA)
- MedDRA Coding & WHO-DD Mapping
- Narrative Writing & Medical Assessment
- Seriousness, Causality, and Expectedness Assessment
- Literature Screening and Case Evaluation
- Argus Safety Database
- Rave EDC & SmartSolve
- Quality Review & QC of ICSRs
- Periodic Safety Update Reports (PSUR/PBRER) Support
- Pharmacovigilance Workflow Management
- Audit and Inspection Readiness
- Team Collaboration & Mentoring
- Good Documentation Practices (GDP)
- MS Office (Word, Excel, PowerPoint)
Timeline
Senior Safety Associate – Pharmacovigilance
Tata Consultancy Services
06.2021 - Current
Junior Data Analyst – Device Complaints
Cognizant Technology Solutions
05.2018 - 05.2021
Master’s - Pharmacy
SP Pune University