Senior Drug Safety Case Manager

The role of Senior Drug Safety Case Manager at Idorsia Pharmaceuticals Ltd. involves ensuring the highest standards of patient safety by managing adverse event cases throughout the product lifecycle. Idorsia is a company focused on drug safety and pharmacovigilance, aiming to monitor medicines effectively. The main day-to-day responsibilities include managing adverse event cases from receipt to submission, which involves triage, data entry, medical coding, narrative writing, quality review, and expedited reporting. This role also involves prioritizing and processing safety cases according to global regulations, identifying missing information, and coordinating follow-up activities. Additionally, the position supports the setup of new clinical studies, contributes to safety reporting documentation, and collaborates with various stakeholders to ensure compliance and data consistency. To qualify for this role, candidates must have a degree in Life Sciences, Pharmacy, Nursing, or a related healthcare discipline, along with a minimum of 5 years of experience in drug safety case management. Proficiency in medical terminology, disease processes, and safety databases is essential. Experience with medical coding dictionaries and safety reporting systems is also required. Knowledge of EU and US pharmacovigilance regulations and reporting requirements is crucial. Strong organizational skills, attention to detail, and the ability to manage multiple priorities are necessary. Fluency in English, both written and spoken, is a must. EU/EFTA citizenship is required due to permit restrictions. Nice-to-have skills include a collaborative mindset and problem-solving abilities. The role is based in Allschwil, Switzerland, offering a dynamic, international environment with opportunities to work with experienced professionals in clinical development and pharmacovigilance. The position is permanent and full-time. What the role asks for: - Degree in Life Sciences, Pharmacy, Nursing, or a related healthcare discipline - 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 - Knowledge of EU and US pharmacovigilance regulations and reporting requirements - Fluency in English, both written and spoken - EU/EFTA citizenship - Strong organizational skills - Strong attention to detail - Ability to manage multiple priorities and meet tight deadlines - Nice-to-have: Collaborative mindset - Nice-to-have: Problem-solving abilities