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Idorsia Pharmaceuticals Ltd is seeking a Drug Safety Scientist to support the benefit-risk evaluation of its products, focusing on patient safety and regulatory compliance. The role requires extensive experience in pharmacovigilance and medical writing, along with strong analytical and communication skills.
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Job Summary
This role leads signal management activities and supports the benefit-risk evaluation of Idorsia's products throughout the product lifecycle.
The successful candidate will act as the lead author for periodic safety reports such as DSURs and PBRERs while ensuring compliance with global regulations.
Idorsia offers a collaborative, multicultural environment where employees can grow their expertise in drug safety and make a meaningful impact on patient health.
Matching Summary
Match Score: 75
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Idorsia Pharmaceuticals Ltd is seeking a Drug Safety Scientist to support the benefit-risk evaluation of its products, focusing on patient safety and regulatory compliance. The role requires extensive experience in pharmacovigilance and medical writing, along with strong analytical and communication skills.
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Skills & Requirements
Must-have
10 years pharmacovigilance experience
Medical writing of DSUR and PBRER
MedDRA coding expertise
Signal management leadership
ICH and EU regulatory knowledge
Nice-to-have
Mentoring junior scientists
Collaborative science-driven environment
Interest in patient safety innovation
Key Requirements
University degree in life science or equivalent
Minimum 10 years in pharmaceutical pharmacovigilance
At least 3 years writing regulatory safety documents