Drug Safety Analyst

• Analyze and process safety data to support aggregate reports and regulatory submissions
• Develop and execute data extraction queries for pharmacovigilance documentation
• Perform database queries to identify interval and cumulative cases for periodic reports
• Generate case listings for regulatory and business needs
• Support signal detection and signal management activities
• Maintain data consistency and integrity within the global safety database
• Support database configuration updates, including: Regulatory submission rules
• Product and study configurations
• Partner with IT to support system validation, testing, and enhancements
• Contribute to continuous system improvements and process optimization
• Ensure compliance with global pharmacovigilance regulations and reporting timelines
• Support audits, inspections, and CAPA activities
• Collaborate with Regulatory Affairs on aggregate safety reporting requirements
• Maintain and support PV documentation (SOPs, WPs, specifications, process flows)
• Review scientific literature and support medical safety assessments
• Develop training materials and support internal knowledge sharing
• Assist with change management and implementation of new systems/processes

• Bachelor’s degree in Health Sciences, Life Sciences, or Information Technology
• 2+ years of pharmacovigilance experience
• 2+ years of safety database or data management experience
• Strong experience with safety data analysis and reporting tools (Business Objects strongly preferred)
• Hands-on experience with: Data extraction queries and reporting
• Database querying for safety case analysis
• Ensuring data integrity within safety systems
• Experience supporting database configuration updates tied to regulatory submissions
• Proficiency in Microsoft Office (Excel, PowerPoint, Visio, Word)
• Experience in GMP environments and/or computer system validation (CSV) (essential)
• Knowledge of E2B (R2) and E2B (R3) standards (preferred)
• Familiarity with: MedDRA
• WHO Drug Dictionary
• Medical terminology
• Strong analytical and problem-solving skills
• Ability to work independently and manage multiple priorities
• Detail-oriented with a focus on data accuracy and compliance
• Effective communicator with cross-functional collaboration experience

Knowledge of E2B (R2) and E2B (R3) standards

• Flexible work arrangement (hybrid/remote potential)
• Long-term contract with competitive pay
• Opportunity to support global pharmacovigilance initiatives
• High-impact role focused on data integrity, compliance, and patient safety