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Leena Rawool

@leenarawool

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Safety Science Analyst at Fortrea Inc. who processed ICSRs end-to-end and progressed to quality review.

India

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What I'm looking for

I'm eager to grow in a dynamic, compliance-driven pharmacovigilance environment focused on patient safety and drug safety monitoring.

At Fortrea Inc. (via Wissen Infotech), I processed ICSRs end-to-end, including data entry, MedDRA and WHO-DD coding, narrative writing, and medical case assessment under SOPs and ICH/GVP guidelines.

I maintained zero critical errors across processed cases while meeting FDA/EMA submission standards. I also progressed to Quality Reviewer, validating peer-processed cases for accuracy, completeness, duplicate detection, and regulatory submission readiness.

At Neon Laboratories Ltd., I managed documentation and regulatory compliance data for exported pharmaceutical products, and supported export tender preparation and submission.

As a Pharmacist at Mehta Pharma, I dispensed medications and counselled patients on drug interactions and safe medication use. I also managed stock, expiry checks, and batch records.

Experience

Work history, roles, and key accomplishments

Safety Science Analyst

Fortrea Inc.

Apr 2025 - Mar 2026 (11 months)

Processed ICSRs end-to-end including data entry, MedDRA/WHO-DD coding, narrative writing, and medical case assessment. Progressed to Quality Reviewer, validating peer-processed cases for accuracy and regulatory submission readiness.

ICSR Case Processing MedDRA WHO DD Oracle Argus Safety Narrative Writing Quality Review Regulatory Compliance ICH Guidelines GVP省令 Data Integrity Duplicate detection

Junior Officer – Export Department

Neon Laboratories Ltd.

Jan 2025 - Apr 2025 (3 months)

Managed documentation and regulatory compliance data for exported pharmaceutical products. Supported preparation and submission of export tenders, coordinating with international clients and internal stakeholders.

Regulatory Compliance Documentation Export Documentation Tender Preparation Client Coordination

Pharmacist

Mehta Pharma

Oct 2022 - Mar 2024 (1 year 5 months)

Dispensed medications and provided patient counselling on drug interactions and safe medication use. Managed stock, expiry checks, and batch records in line with storage and handling guidelines.

Medication dispensing Patient Counseling Drug interaction screening Stock Management Batch Records Storage And Handling