Key responsibilities

• Manage collection, processing, documentation, reporting, and follow-up of all adverse event reports for Novartis products from clinical trials, NIS, patient programs, literature, and spontaneous reports
• Transcribe, translate, and accurately enter safety data into patient safety systems with emphasis on timeliness and quality
• Prepare and submit safety reports, including SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR listings, and DSUR to Local Health Authorities and clinical operations
• Collaborate with global and local Patient Safety associates to ensure accurate safety data evaluation
• Interact with regulatory authorities, other functional groups, and third-party contractors regarding safety information
• Monitor and update local pharmacovigilance regulations, implementing compliance procedures accordingly
• Review Phase IV clinical trial and NIS protocols safety sections and oversee CRO safety responsibilities if applicable
• Develop, update, and deliver training materials for pharmacovigilance, ensuring staff and field force compliance
• Manage and maintain Patient Safety databases and filing/archive systems
• Support execution and monitoring of Risk Management Plans (RMP), including training, alignment with sales/marketing, and reporting of local RMP commitments
• Prepare KPI reports on compliance, identify root causes for delays, and implement corrective actions
• Participate in audits, inspections, and corrective action plans as required
• Liaise with cross-functional teams including Clinical Research Operations, Medical, Regulatory Affairs, and Sales/Marketing to ensure alignment in Patient Safety and RMP activities