Sheeba S Koshy
@sheebaskoshy
Drug safety associate with pharmacovigilance expertise and strong ICSR quality review skills.
United Arab EmiratesWhat I'm looking for
I am a Drug Safety Associate with three years of hands-on experience in pharmacovigilance, case processing, and ICSR quality review. I have managed complex safety data, validated MedDRA coding, and ensured timely reporting to meet ICH and local regulatory requirements.
Throughout my roles at IQVIA India, I reviewed and validated individual case safety reports in ArisG and LSMV for accuracy, completeness, and regulatory compliance, collaborated with case processors and medical reviewers, and provided feedback to correct inconsistencies.
I am committed to patient safety and data integrity, skilled in seriousness, causality, and expectedness assessment, and focused on continuous improvement of safety data quality and regulatory adherence.
Experience
Work history, roles, and key accomplishments
Reviewed and validated ICSRs in ArisG and LSMV, ensuring completeness and regulatory compliance while assessing seriousness, causality, and expectedness to support timely safety reporting.
Supported case processing by coding adverse events in MedDRA, drafting case narratives, and processing serious adverse event assessments to meet ICH and local reporting requirements.
Education
Degrees, certifications, and relevant coursework
JKKM College of Pharmacy
Doctor of Pharmacy, Pharmacy
2016 - 2022
Completed a Doctor of Pharmacy program with training in pharmacology, clinical research, and drug safety.
Availability
Location
United Arab EmiratesAuthorized to work in
Job categories
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