Pharmacovigilance Submission Specialist

Role & Responsibilities
• Manage and execute ICSR regulatory submissions for clinical and post-marketing products
• Perform global safety submissions within regulatory timelines
• Handle case processing and submissions in ARGUS Safety database
• Review AE data and local labeling for accurate scheduling
• Monitor submission workflows and resolve pending or failed submissions
• Perform major corrections and case distribution
• Ensure compliance with global PV regulations, SOPs, WRKs, MANs, and BEDs
• Maintain submission tracking and documentation
• Identify data gaps and quality issues

Qualification
• B.Pharm or M.Pharm

Experience
• 1–4 years in Pharmacovigilance Submission
• Experience with ARGUS, ICSR processing, and global regulatory reporting

Skills
• ARGUS Safety handling
• ICSR submissions and distribution
• Medical terminology and clinical interpretation
• Quality control in PV
• Documentation and workflow monitoring
• Strong organizational and communication skills

About the Company
• A leading ITES organization hiring through Outpace Consulting Services
• Focused on global pharmacovigilance and regulatory compliance
• Provides exposure to international safety submissions and structured compliance processes