Idorsia is seeking a motivated Safety Scientist to support the benefit–risk evaluation of Idorsia’s products and contribute to patient safety throughout the product lifecycle. The role involves leading signal management activities, contributing to periodic safety reports, and providing expertise on global pharmacovigilance regulations and guidelines.
Requirements
- University degree in life science (e.g., pharmacy, nursing, M.Sc., or Ph.D.) or equivalent education in health-related field
- At least 10 years of experience in pharmacovigilance in the pharmaceutical industry
- Excellent medical writing skills and at least 3 years of experience in writing regulatory safety documents (e.g., DSURs, PBRERs/PSURs, and/or Integrated Safety Summary (ISS), clinical study reports etc.)
- Solid knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines (ICH guidelines, European Union [EU], FDA [US])
- Excellent communication, interpersonal and problem-solving skills
- Strong organizational skills and ability to work within tight timelines with effective project management skills
- Effective communication in English (both verbally and in writing)
- Excellent knowledge of MedDRA coding thesauri and SMQs and WHO drug dictionary and SDGs
- Strong analytical skills with attention to details
Benefits
- Development – opportunities to grow, learn, and expand your expertise in a dynamic and international organization
- A collaborative culture – a supportive, solution-oriented environment where teamwork, initiative, and new ideas are encouraged
- International exposure – work in a truly multicultural setting with colleagues and partners from around the world