Bushra Sheikh

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.