Summary
Overview
Work History
Education
Skills
Timeline
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Swarada Uplap

Specialist II, Patient Safety Solutions
Pune

Summary

I am a dedicated pharmacovigilance professional with 6 year plus experience in Individual Case Safety Report (ICSR) processing and quality review. My technical proficiency includes MedDRA, ARGUS, ARISg, and SCEPTRE, and I currently serve as the Subject Matter Expert (SME) for my team—leading query resolution, conducting training sessions, guiding team. I am known for my reliability, attention to detail, and collaborative approach to problem-solving.
Looking ahead, I aspire to grow into strategic roles within global pharmacovigilance and regulatory affairs, where I can contribute to shaping safety frameworks and mentoring future professionals in the field.

Overview

9
9
years of professional experience
1
1
Language

Work History

Specialist II, Patient Safety Solutions

Fortrea Scientific Pvt. Ltd.
01.2019 - Current
  • Managing for the receipt, review, and processing of adverse event reports from diverse sources including spontaneous, market research, social media, clinical study, Health authority, business partner and literature, ensuring compliance with safety database conventions and client-specific systems.
  • Perform ICSR processing using ARGUS, ARISg, and SCEPTRE safety databases with precision and timeliness.
  • Contributed to case intake, duplicate checks, and registration processes.
  • Execute coding activities for suspect drugs, procedures, and indications, using appropriate medical dictionaries.
  • Demonstrate proficiency in narrative writing by summarizing case information across all report types.
  • Create follow-up requests, manage workflows, and generate reports from electronic data capture systems.
  • Perform labeling for serious and non-serious cases in accordance with regulatory standards.
  • Conduct quality checks to ensure completeness, consistency, and accuracy of safety data and regulatory reporting forms (MedWatch, CIOMS I).
  • Ensure scientific rigor through accurate and timely data entry of adverse event reports from source documents.
  • Provide constructive feedback and conduct root cause analyses (RCAs) to address recurring issues in case processing.
  • Deliver targeted quality improvement training sessions to enhance team performance and reduce errors.
  • Act as SME by resolving queries and support team members through one-on-one guidance, query resolution calls and providing team members recent updates.
  • Address and manage requests from external stakeholders with professionalism and clarity.
  • Provide mentorship and training to junior staff in case.
  • Sustained individual case quality score exceeding 95%
  • Participated in quality discussion calls with clients to review case trends, address recurring issues, and align on process improvements, and compliance expectations.

Teacher

Vidya Education Classes
04.2016 - 12.2018

Education

Post Graduate Diploma - Clinical Research, Pharmacovigilance, And Clinical Data Management

MITCON Biopharma
Pune
12-2024

Bachelor’s Degree - Pharmacy

Sinhgad Institute of Pharmacy
Pune
01.2018

Skills

  • ICSR case processing and quality review
  • Adverse event reporting
  • Narrative writing
  • Training and mentorship
  • MedDRA coding
  • Query resolution and guidance
  • Regulatory Compliance
  • Safety Data Reconciliation and Audit Support
  • ARISg
  • ARGUS
  • Sceptre
  • MEDDRA Coding
  • Collaborative Teamwork
  • Communicator
  • Effective Decision-Making

Timeline

Specialist II, Patient Safety Solutions

Fortrea Scientific Pvt. Ltd.
01.2019 - Current

Teacher

Vidya Education Classes
04.2016 - 12.2018

Post Graduate Diploma - Clinical Research, Pharmacovigilance, And Clinical Data Management

MITCON Biopharma

Bachelor’s Degree - Pharmacy

Sinhgad Institute of Pharmacy

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Swarada UplapSpecialist II, Patient Safety Solutions