Pharmacovigilance Analyst
Current• Review cases on a global scale for validity, event term accuracy, causality, and seriousness, ensuring precise product coding and accurate evaluation of listedness.• Maintain data consistency and cohesion in the Safety Database, documenting key activities during case processing.• Perform MedDRA coding for regulatory activities, adhering to conventions and mastering labeling documents.• Conduct QC/QA for ICSRs at CONTINUUM, ensuring compliance and high-quality metrics.• Analyze trends in data, reporting issues from QC/QA results to Team Leads/Project Manager/client.• Provide support in audits, inspections, and readiness activities for pharmacovigilance processes.• Verify critical/non-critical fields and conformity to E2B standards in quality checks.• Mentored Quality Scientists, offering refresher training on project-specific guidelines.• Manage activities related to ICSR processing, including case validation and data entry.• Maintain expertise in safety profiles, ICSR conventions, guidelines, procedures, and international safety regulations for assigned vaccines and drugs.
