Safety submissions specialist

Precision for Medicine(4 days ago)

Bangalore, Karnataka, IndiaOnsiteFull TimeMedior$60,000 - $80,000Regulatory Affairs

About this role

This role involves reviewing safety reports and ensuring compliance with global safety reporting regulations in a regulatory or clinical trials context. The specialist supports the submission and reconciliation of safety data to regulatory agencies and internal systems, maintaining documentation and monitoring regulatory updates.

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Required Skills

Regulatory Affairs
Safety Reporting
ICSR
GCP
ICH Guidelines
Pharmacovigilance
ARGUS Safety Database
EudraVigilance
MedWatch
CAPA

Qualifications

About Precision for Medicine

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