Drug Safety Case Manager

Idorsia seeks a Drug Safety Case Manager in Allschwil to oversee adverse event reporting and ensure regulatory compliance within its global pharmacovigilance team.

This position is embedded within the Global Business Development, Drug Safety business area, where it supports a collaborative and highly skilled team. The primary purpose of the role is to safeguard patient health by managing safety information accurately and promptly throughout the entire product lifecycle.

Responsibilities

• Handle adverse event cases from initial receipt to final submission, covering triage, data entry, medical coding, narrative creation, quality checks, and expedited reporting.
• Process safety cases according to global regulations, standard operating procedures, and strict reporting deadlines.
• Detect gaps or incomplete data and liaise with Drug Safety Physicians and other stakeholders to resolve issues.
• Track case workflows to guarantee efficient and compliant processing.
• Assist with or lead reconciliation efforts to maintain data consistency across various systems.
• Help launch new clinical studies by supplying safety reporting documentation, reconciliation plans, monitoring guidance, and Trial Master File (TMF) records.
• Facilitate Serious Adverse Event (SAE) reconciliation between clinical and safety databases.
• Manage SUSAR notifications directed at investigators and Ethics Committees.
• Partner with internal teams and external partners, such as CROs, to define and uphold safety agreements and processes.

Requirements

• A degree in Life Sciences, Pharmacy, Nursing, or a related healthcare field.
• At least five years of professional experience in drug safety case management.
• Solid grasp of medical terminology, disease mechanisms, and safety databases.
• Practical experience using medical coding dictionaries and safety reporting systems.
• Strong knowledge of EU and US pharmacovigilance regulations and reporting obligations.
• Fluent proficiency in English, both written and spoken.
• EU or EFTA citizenship is mandatory due to work permit restrictions.

What the company offers

• Direct contribution to patient safety outcomes.
• Employment in a dynamic, international setting.
• Collaboration with seasoned experts in clinical development and pharmacovigilance.
• Involvement in innovative clinical programs.

About the company

Idorsia fosters a workplace culture that leverages diversity, authenticity, and inclusion to drive business success.

• Emphasis on harnessing differences and promoting an inclusive environment.