Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

Job Description:

• 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

Requirements:

• High school diploma required
• Post-secondary education in a life sciences discipline is preferred
• Equivalent professional experience in pharmacovigilance regulatory submissions or regulatory intelligence will also be considered
• Minimum of 3 years' experience working with pharmacovigilance safety databases
• Experience with safety reporting, ICSR submissions, E2B exchanges, and regulatory compliance activities preferred
• Experience with Oracle Argus Safety or similar safety databases highly desirable
• Knowledge of xEVMPD and global pharmacovigilance regulations is an advantage
• Strong attention to detail and commitment to quality
• Excellent verbal and written communication skills
• Strong organizational and problem-solving abilities
• Ability to manage multiple priorities and adapt to changing business needs
• Ability to work independently while collaborating effectively within cross-functional and global teams
• Proficiency in Microsoft Office applications, including Outlook, Word, and Excel

Benefits:

• Work with a global team of pharmacovigilance and regulatory experts
• Gain exposure to international safety reporting requirements and health authority interactions
• Contribute to meaningful projects supporting patient safety and regulatory compliance worldwide
• Develop expertise across submissions, regulatory intelligence, testing, and PV systems
• Hybrid working encouraged for new hires based within a reasonably short commute of an office, as agreed with the manager
• Equal Opportunity Employer workplace committed to diversity, equity, and inclusion

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