Excelya
Biotech
MedicalSafetyReviewer
“Medical Safety Reviewer at Excelya. Skills: Pharmacovigilance, ICSR review, Regulatory compliance. Perform medical review of ICSRs. Manage complex/high-priority cases”
What You'll Achieve.
Ensure submission readiness; Ensure global consistency
Industry & Context.
Problem-solving; Analytical
What They're Looking For.
Must Have
PhD or Medical Degree (MD), 6-8 years pharmacovigilance experience, ICSR medical review experience, PV regulations knowledge, ICSR management experience, Reporting experience, Literature surveillance experience, Safety data systems experience
Nice to Have
Operational oversight experience, Cross-functional collaboration experience, Vendor management experience
What You'll Do.
Perform medical review of ICSRs
Manage complex/high-priority cases
Ensure data quality and consistency
Conduct targeted QC activities
Drive corrective/improvement actions
Lead follow-up activities
Oversee coding standards
Ensure global consistency
Contribute to PV standards
Contribute to training
Contribute to continuous improvement
Support benefit-risk evaluation
Support safety strategy activities
Act as SME for audits
Act as SME for inspections
Drive operational performance
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Internal teams; HCPs; Vendors
Communication Scope
Explain complex topics
Process & Methodology
Project management
Applying for this Medical Safety Reviewer role?
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