Open to opportunities

Bushra Sheikh

@bushrasheikh

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PV Specialist with proven ICSR, regulatory reporting, and Argus expertise.

India

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What I'm looking for

I seek PV roles focused on end-to-end ICSR processing, regulatory submissions, and narrative quality in a compliance-driven team with growth opportunities.

I am a Pharmacovigilance (PV) Specialist with nearly four years of hands-on experience in ICSR management and regulatory reporting, consistently delivering high-quality safety documentation and on-time submissions to global health authorities.

I have processed 250+ global ICSR cases monthly using Argus 8.1/8.2, authored complex SAE/SUSAR narratives, performed MedDRA 26.1 coding, and executed expedited 7-/15-day submissions for FDA, EMA, MHRA and other agencies while maintaining 98% quality compliance.

I collaborate closely with Medical Reviewers to resolve queries, align clinical assessments, and ensure audit-ready documentation in compliance with SOPs, GVP, ICH-GCP and 21 CFR standards; I am available for immediate onboarding and actively pursuing PV Specialist roles.

Experience

Work history, roles, and key accomplishments

Operation Specialist 1

IQVIA RDS India Pvt Ltd

Dec 2023 - Feb 2025 (1 year 2 months)

Processed 250+ global ICSR cases/month in Argus, maintaining 98% quality and 100% on-time 7-/15-day regulatory submissions; prepared SAE/SUSAR narratives and coordinated medical review for oncology and CNS workflows.

ICSR Case Processing SAE SUSAR Narrative Writing E2B(R3) Reporting

Safety Associate

IQVIA RDS India Pvt Ltd

Jul 2022 - Dec 2023 (1 year 5 months)

Independently processed ICSR cases with MedDRA coding, performed seriousness/expectedness/causality assessments, and supported regulatory submissions and SAE narrative writing for global clinical studies.

MedDRA Seriousness Causality Assessment CIOMS Literature Screening Regulatory Submissions

Safety Associate Trainee

IQVIA RDS India Pvt Ltd

Jun 2021 - Jul 2022 (1 year 1 month)

Supported case intake, triage, MedDRA coding and duplicate checks in Argus, assisted drafting safety narratives, and maintained audit-ready documentation to support expedited reporting workflows.

Duplicate Checks 7 15 Day Submission Support