Ishani User

IU

Looking for a job

Ishani User

@ishanikalra

I build audit-ready clinical and regulated R&D documentation and data workflows.

What I'm looking for

I'm seeking an entry-level role in pharmacovigilance, clinical data management, or clinical operations where I can apply my GCP, regulated documentation, data evaluation, and drug-safety training.

I've supported regulated R&D at IPL Biologicals Limited by maintaining GLP/GDP-compliant batch records, stability data, calibration logs, and technical documentation for international client evaluations. I also performed quality control, analytical evaluation, formulation trials, and stability trend analysis, and was recognized as Employee of the Year.

My microbiology and quality-testing experience at Varun Beverages and Fresenius Kabi Oncology strengthened my foundation in SOP compliance, environmental monitoring, microbial testing, GMP, and audit support. I'm trained in pharmacovigilance, ICSR processing, MedDRA coding, clinical data management, GCP, CDISC, and Indian clinical-trial regulations.

Experience

Work history, roles, and key accomplishments

IL

R&D Executive - Formulation & Product Development

IPL Biologicals Limited

May 2023 - Jan 2026 (2 years 8 months)

Maintained GLP/GDP-compliant documentation and performed quality control and analytical evaluation of product samples. Designed and executed formulation trials, conducted stability studies, and mentored six interns.

GLP GDP Quality Control Analytical Evaluation Formulation Stability Studies Documentation Mentorship

VL

Intern - Microbial Quality & Product Testing

Varun Beverages Limited

Jan 2023 - May 2023 (4 months)

Performed microbial testing and environmental monitoring per SOPs, documented results in compliance with GLP, and supported cross-functional audits.

Microbial Testing Environmental Monitoring GLP SOP Compliance Audit

FL

Intern - Pharmaceutical Microbiology & Quality Testing

Fresenius Kabi Oncology Limited

Jun 2022 - Jul 2022 (1 month)

Performed bioburden testing, BET, and microbial limit testing on pharmaceutical batches. Executed antimicrobial effectiveness and particulate testing per USP standards.

Bioburden Testing BET Microbial Limit Testing Antimicrobial Effectiveness Testing Particle Count Testing GMP

Education

Degrees, certifications, and relevant coursework

FR

FreeGCP.com

Good Clinical Practice Certification, Clinical Research

Good Clinical Practice certification (ICH E6 R3) from FreeGCP.com, completed in September 2026.

CI

Clini India

Advanced Program in Clinical Research and Management, Clinical Research

Advanced Program in Clinical Research and Management, completed in December 2024.

AP

Amity University, Uttar Pradesh

Master of Science, Microbiology

2021 - 2023

Master of Science in Microbiology from Amity University, Uttar Pradesh, completed in 2023.

UD

University of Delhi

Bachelor of Science, Microbiology

2018 - 2021

Bachelor of Science in Microbiology from the University of Delhi, completed in 2021.

Tech stack

Software and tools used professionally

Microsoft Excel

Microsoft Word

Availability

Looking for a job

Location

India

Authorized to work in

Salary expectations

450k-550k INR

Social media

Job categories

Pharmacovigilance Associate Clinical Research Associate Clinical Operations Associate Clinical Research Coordinator

Skills

Pharmacovigilance Drug Safety ICH GCP ICH Good Clinical Practice (E6 R3)ICH E2A ICH E2E ICSR Processing Adverse Event Reporting Serious Adverse Events (SAEs) Monitoring SUSARs MedDRA Coding Oracle Argus Safety Signal Detection Post Marketing Surveillance PvPI Guidelines Clinical Trial Lifecycle Site Initiation Monitoring Visits Close Out Visits Source Documentation Verification (SDV)Query Management Deviation Management CAPA Investigational Product Accountability Informed Consent Forms Risk Based Monitoring Clinical Data Management CRFs Review ECRF Review Trial Master File Management Investigational Site File (ISF)CDISC CDISC CDASH SDTM Medidata EDC Oracle InForm Database Lock SAE SUSAR Narrative Writing SOP Development NDCT Rules 2019 CDSCO CTRI Registration Ethics Submissions GLP GDP GMP ISO 9001 Quality Control Analytical Evaluation Medical Terminology Cross Functional Collaboration Excel Microsoft Word Stability Studies Environmental Monitoring Microbial Testing Bioburden Testing Bacterial Endotoxin Testing Microbial Limit Testing Antimicrobial Effectiveness Testing Particle Count Testing Microbial Identification Aseptic Technique

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