Senior Drug Safety Case Manager - Patient Safety Lead

Idorsia Pharmaceuticals Ltd; Basel; On-site; CHF 110,000 - 140,000; Full time

Job summary

Idorsia Pharmaceuticals Ltd in Basel, Switzerland is seeking a Drug Safety Case Manager to lead adverse event case management across the product lifecycle. You will collaborate with physicians, clinical teams, regulatory colleagues, and external partners to ensure timely and compliant safety reporting for both clinical trials and post-marketing cases.

The ideal candidate holds a degree in Life Sciences, Pharmacy or Nursing, has 5+ years in drug safety case management, and possesses strong

Qualifications

• 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.
• Degree in Life Sciences, Pharmacy, Nursing, or related healthcare discipline.
• Fluent English, both written and spoken.
• EU/EFTA citizenship is required due to permit restrictions.
• Excellent organizational skills with ability to manage multiple priorities and tight deadlines.

Responsibilities

• Manage adverse event cases from receipt through submission, including triage, data entry, narrative writing, and expedited reporting.
• Prioritize safety cases in accordance with global regulations, SOPs, and timelines.
• Identify missing or incomplete information and coordinate follow-up with Drug Safety Physicians and stakeholders.
• Monitor case workflows to ensure efficient processing and compliance.
• Support reconciliation activities to ensure data consistency across systems.
• Coordinate SAE reconciliation and SUSAR notifications to investigators and Ethics Committees.

Skills

Medical terminology

Safety databases

Medical coding

Education

Life Sciences/Pharmacy/Nursing degree

Tools

Safety reporting systems

Job description

Idorsia Pharmaceuticals Ltd in Basel, Switzerland is seeking a Drug Safety Case Manager to lead adverse event case management across the product lifecycle. You will collaborate with physicians, clinical teams, regulatory colleagues, and external partners to ensure timely and compliant safety reporting for both clinical trials and post-marketing cases.

The ideal candidate holds a degree in Life Sciences, Pharmacy or Nursing, has 5+ years in drug safety case management, and possesses strong