Submission Analyst in Bangalore, भारत

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