Drug Safety Case Manager

Idorsia Pharmaceuticals

Allschwil, Switzerland

Are you passionate about patient safety and ensuring that medicines are monitored to the highest standards? As a Drug Safety Case Manager, you will play a critical role in safeguarding patients by ensuring accurate and timely management of safety information throughout the product lifecycle.

Working within a collaborative and highly skilled Drug Safety team, you will take ownership of adverse event case management activities while partnering closely with physicians, clinical teams, regulatory colleagues, and external partners to ensure compliance with global pharmacovigilance requirements.

Your Responsibilities:

Case Management & Safety Reporting

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.

Clinical Trial & Cross-Functional Support

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.

What You'll Bring:

Degree in Life Sciences, Pharmacy, Nursing, or a related healthcare discipline;
Minimum 5 years of experience in drug safety case management;
Strong understanding of medical terminology, disease processes, and safety databases;
Experience with medical coding dictionaries and safety reporting systems;
Good knowledge of EU and US pharmacovigilance regulations and reporting requirements;
Excellent organizational skills with the ability to manage multiple priorities and meet tight deadlines;
Strong attention to detail, problem-solving abilities, and a collaborative mindset;
Fluent English, both written and spoken;
EU/EFTA citizenship is required due to permit restrictions.