Drug Safety Associate
About the Role
About the role & responsibilities
• Perform triage and case validity assessment of adverse event reports
• Execute MedDRA and WHO-DD coding
• Conduct duplicate checks and quality control of safety cases
• Ensure compliance with ICH-GCP, 21 CFR Part 11 and global PV regulations
• Maintain audit-ready safety data within digital PV systems
• Provide subject matter expertise to improve safety platform workflows
• Support reconciliation and safety data reviews
Qualification
• PharmD (mandatory)
Experience
• 0 – 4 years
Skills
• MedDRA & WHO-DD coding
• Case validity & triage
• Pharmacovigilance compliance
• Data quality control
• Microsoft Excel & Word
About the company
• CoReason.ai is a fast-growing HealthTech company building advanced analytics platforms for life sciences and healthcare organizations
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