Summary
Overview
Work History
Education
Skills
Certification
Interests
Accomplishments
Hobbies
Timeline
Generic
SIRISHA TR

SIRISHA TR

Pharmacovigilance Associate
BENGALURU

Summary

Pharmacovigilance Associate with expertise in drug safety operations, including Individual Case Safety Report (ICSR) processing, MedDRA coding, and narrative writing. Proficient in safety database management (e.g., Argus) and committed to ensuring compliance with global regulatory standards like FDA and GVP guidelines. Strong grasp of pharmacological terminology, adverse event reporting, and data privacy. Known for attention to detail, quick learning, and maintaining accuracy in high-volume environments.

Overview

1
1
year of professional experience
2
2
Certifications
4
4
Languages

Work History

Pharmacovigilance Associate

Accenture
12.2024 - Current
  • Processed Individual Case Safety Reports (ICSRs) from various sources including spontaneous, solicited, and Non-interventional Studies (NIS).
  • Participated in quality review of cases, ensuring compliance with SOPs and minimizing errors in safety data.
  • Performed comprehensive data entry, MedDRA coding (events + product), and narrative writing in alignment with global regulatory requirements.
  • Conducted initial medical assessment,seriousness determination and supported case follow-up activities.
  • Worked on batch cases and contributed to case merging and deactivation activities in the safety database(eg.,Argus)
  • Assited in resolving case processing queries raises by quality or audit teams;supported internal and client PV audits.
  • Contributed to mentoring and onboarding of new team members by sharing best practices in PV operations.
  • Reviewed and validated selected cases for completeness,accuracy and regulatory compliance under supervision.
  • Gained exposure to signal detection concepts, compliance metrics and pharmacovigilance workflow managment.
  • Reduced workload backlog by effectively prioritizing high-priority cases based on severity level and regulatory deadlines during peak periods of volume influx.
  • Enhanced patient safety by meticulously reviewing and analyzing adverse event reports.

Education

Bachelor of Pharmacy -

PES University
04.2001 -

Internship -

Karnataka Antibiotics And Pharmaceuticals Limited
07.2023

Skills

  • ICSR Case Processing & Narrative Writing
  • MedDRA Coding (Medical Dictionary for Regulatory Activities)
  • Case Follow-up (CFL) Management
  • Serious & Non-Serious Case Handling
  • Effective Communication & Team Collaboration
  • Critical Thinking & Analytical Skills
  • Safety database – Argus
  • Attention to Detail & Accuracy
  • Adaptability in Fast-Paced Environments
  • Process-Oriented & Quality-Focused
  • Microsoft Excel
  • Microsoft Word

Certification

ADVANCED DIPLOMA CLINICAL RESEARCH (01/2024 - 08/2024)

Interests

Drug Safety and Pharmacovigilance

Clinical Research and Development

Regulatory Affairs

Adverse Event Reporting and Analysis

Accomplishments

  • Co-pilot award at Accenture (09/2025 - Present):

    • Awarded the Co-Pilot Award at Accenture for demonstrating outstanding efficiency and rapid adaptability in project delivery.

  • Distinction Award (12/2020 - 05/2024):

    • Graduated with Distinction in B.Pharmacy, recognizing consistent academic excellence.

  • Calligraphy Award (12/2019 - 01/2020):

    • Received Calligraphy Award in Class 12 for artistic handwriting and visual presentations.

Hobbies

Language learning 

Creative Arts

Timeline

Pharmacovigilance Associate

Accenture
12.2024 - Current

Bachelor of Pharmacy -

PES University
04.2001 -

Internship -

Karnataka Antibiotics And Pharmaceuticals Limited

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SIRISHA TRPharmacovigilance Associate