The Submission Analyst within Global Pharmacovigilance manages electronic distribution and submission of individual case safety reports to regulatory authorities. The role involves maintaining submission rules in the pharmacovigilance database, monitoring ICSR transmissions, and collaborating across safety and regulatory functions.
Responsibilities
Create and issue regulatory reports including individual case safety reports
Run and monitor electronic submissions of ICSRs to regulatory authorities and business partners
Support setup and maintenance of electronic submission rules in the pharmacovigilance database
Participate in peer review of safety submissions from team members
Troubleshoot E2B data rejections and coordinate corrections with regulatory agencies
Requirements
Bachelor's degree in computer science, life sciences, or equivalent
Solid knowledge of pharmacovigilance terminology and ICH E2B standards
One year experience in safety submissions, pharmacovigilance, regulatory affairs, or clinical research
Strong analytical and problem-solving skills with attention to detail
Excellent written and oral communication abilities
Technical proficiency with databases, spreadsheets, and relevant systems
Knowledge of medical terminology and global safety database systems
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