Tanuja Koundal
Drug Safety Associate
Kangra
Summary
Detail-oriented and dedicated M.Sc. Pharmacovigilance & Clinical Research candidate with hands-on experience in literature screening, ICSR processing, data intake and triage, and regulatory compliance. Proficient in pharmacovigilance database systems, including LifeSphere MultiVigilance and MedDRA coding, with a solid understanding of GVP, ICH, and E2B guidelines. Known for ensuring data integrity and accuracy while maintaining timelines and safety compliance.
Overview
1
1
year of professional experience
2025
2025
years of post-secondary education
2
2
Certifications
2
2
Languages
Work History
Pharmacovigilance Intern
Harom Solutions Pvt. Ltd.
01.2025 - 04.2025
- Performed end-to-end literature screening of over 250+ articles to extract and assess safety data.
- Conducted data intake and triage to prioritize and classify ICSRs in line with urgency and seriousness.
- Executed accurate and timely data entry into LifeSphere MultiVigilance, ensuring 95% regulatory compliance.
- Applied MedDRA coding to ensure accurate classification of adverse events.
- Maintained case quality by adhering to ICH-GVP guidelines and internal SOPs.
- Participated in workshops and presentations related to projects to gain knowledge.
- Improved coding efficiency with introduction of automated testing scripts.
Case Intake and Trige
Chitkara University
09.2024 - 10.2024
- Performed case intake from the literature screening team and conducted comprehensive assessments including seriousness, validity, and expectedness, followed by accurate and timely case entry into the safety database in compliance with regulatory standards.
- Self-motivated, with a strong sense of personal responsibility.
- Excellent communication skills, both verbal and written.
- Skilled at working independently and collaboratively in a team environment.
Education
M.Sc. - Pharmacovigilance & Clinical Research
Chitkara University
01.2023 - 01.2025
B.Sc. - Chemistry
MCM DAV College
Kangra, HPSkills
ICSR Processing & Case Entry
Certification
Signal Detection, UMC, 2023
Accomplishments
- Processed 500+ Individual Case Safety Reports (ICSRs) with 95% compliance with global regulatory timelines.
- Successfully applied MedDRA and WHO-DD coding in safety databases with zero major QC findings.
Research Interests
- Detection & Management of Drug Safety Signals
- Regulatory Strategy & Global Compliance
- Real-World Evidence in Drug Safety
- Innovation in Clinical Methodologies
Place Of Declaration
Chandigarh
Technical Tools
- LifeSphere MultiVigilance
- E2B-Compliant Safety Systems
- MedDRA, WHO-DD, ATC Classification
- Microsoft Office Suite
Additional Information
Processed 500+ Individual Case Safety Reports (ICSRs) with 95% compliance with global regulatory timelines.
Successfully applied MedDRA, WHO-DD coding and ATC coding in safety databases with zero major QC findings.
Disclaimer
I hereby declare that the above information is true to the best of my knowledge.
Timeline
Pharmacovigilance Intern
Harom Solutions Pvt. Ltd.
01.2025 - 04.2025
Case Intake and Trige
Chitkara University
09.2024 - 10.2024
M.Sc. - Pharmacovigilance & Clinical Research
Chitkara University
01.2023 - 01.2025
B.Sc. - Chemistry
MCM DAV College
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