Senior Drug Safety Case Manager

About the role

Idorsia is looking for a Senior Drug Safety Case Manager in Allschwil, Switzerland, within its Global Business Development, Drug Safety business area. The role safeguards patients by managing safety information accurately and on time throughout the product lifecycle, working in a collaborative Drug Safety team with physicians, clinical teams, regulatory colleagues and external partners.

Key responsibilities

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

Required profile

• Degree in Life Sciences, Pharmacy, Nursing or a related healthcare discipline
• At least 5 years of experience in drug safety case management
• EU/EFTA citizenship is required due to permit restrictions

Required skills

• Medical terminology, disease processes and safety databases
• Medical coding dictionaries and safety reporting systems
• Knowledge of EU and US pharmacovigilance regulations and reporting requirements
• Fluent written and spoken English