Compliance

• Manage and monitor expedited and non-expedited Individual Case Safety Report (ICSR) submissions and exchanges
• Ensure compliance with global pharmacovigilance reporting requirements and internal procedures
• Conduct monthly ICSR reconciliation activities with clients and safety partners
• Support gateway-to-gateway testing for health authority submissions and safety partner exchanges
• Assist with investigation, documentation, and resolution of submission-related deviations and CAPAs
• Generate Argus-based line listings and summary tabulations for periodic safety reports
• Assist in creating, validating, and quality reviewing custom reports and reporting outputs
• Support setup, verification, and maintenance of periodic reporting requirements across global markets
• Coordinate periodic report submissions in compliance with local regulatory requirements
• Support pharmacovigilance reporting services and operational excellence
• Research, collect, and maintain global pharmacovigilance reporting requirements
• Conduct monthly regulatory surveillance and impact assessments
• Support regulatory intelligence tools, mailboxes, tickets, queries, and ad hoc projects
• Provide guidance on evolving pharmacovigilance regulations and reporting obligations
• Perform Performance Qualification (PQ) testing for Argus upgrades, patches, and custom developments
• Support implementation and validation of territory-specific and custom E2B profiles
• Participate in data migration testing and submissions-related system enhancements
• Contribute to projects improving efficiency, quality, and system performance
• Prepare and maintain xEVMPD submissions, updates, removals, and new product entries
• Conduct peer review and quality control of xEVMPD submissions
• Support bulk updates, QPPV changes, master file location updates, and developmental product registrations

Compliance jobs in North Macedonia

Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions