Senior Drug Safety Case Manager

Are you passionate about patient safety and ensuring that medicines are monitored to the highest standards? In this role, you will play a critical part in safeguarding patients by ensuring accurate and timely management of safety information throughout the product lifecycle. You will work within a collaborative and highly skilled Drug Safety team, partnering closely with physicians, clinical teams, regulatory colleagues, and external partners to ensure compliance with global pharmacovigilance requirements.

• Manage adverse event cases from receipt through submission, including triage, data entry, medical coding, narrative writing, quality review, and expedited reporting for both clinical trial and post-marketing cases
• Prioritize and process safety cases in accordance with global regulations, SOPs, and reporting timelines
• Identify missing or incomplete information and coordinate follow-up activities with Drug Safety Physicians and other stakeholders
• Monitor case workflows to ensure efficient and compliant case processing
• Support or oversee reconciliation activities to ensure data consistency across systems
• Contribute to the successful set-up of new clinical studies by providing safety reporting documentation, reconciliation plans, monitoring guidance, and TMF documentation
• Support SAE reconciliation activities between clinical and safety databases
• Coordinate SUSAR notifications to investigators and Ethics Committees
• Collaborate with internal and external stakeholders, including CROs, to establish and maintain safety agreements and processes