The Safety Scientist plays a critical role in the benefit-risk evaluation of Idorsia products by:
Leading signal management activities
Planning and drafting periodic safety reports (DSUR, PBRER)
Supporting the Drug Safety Physician with safety data analysis and the assessment of product safety profiles
Providing expertise on global safety regulations and guidelines
Safety Signal Tracking and Management
Serves as the Secretary of the Idorsia Drug Safety Committee (DSC), evaluating the safety profiles of both investigational and marketed compounds
Assists the Drug Safety Physician in the medical safety evaluation of identified safety signals and the preparation of responses to safety queries from health authorities
Leads safety signal tracking and management efforts, ensuring proper documentation and oversight of new safety signals and timely completion of safety measures
Monitors PRAC meeting documents and other relevant sources, informing the responsible Drug Safety Physician and the Head of GDS of any pertinent safety information regarding Idorsia's products (e.g., same class, competitors)
Periodic Safety Reporting and Medical Writing
Coordinates the planning schedule and allocation of responsibilities for the preparation and submission of regulatory aggregated periodic safety reports to health authorities
Works closely with other departments (e.g., Drug Regulatory Affairs, Clinical Pharmacology, Clinical Science, Global Medical Affairs) to ensure accurate and timely contributions to aggregated periodic safety reports
Acts as the lead author in collaboration with the responsible Drug Safety Physician on the medical writing of periodic safety reports and other ad-hoc safety analysis reports
Participates in reviewing medical and scientific literature relevant for inclusion in periodic safety reports
Collaborates with colleagues in Drug Regulatory Affairs to ensure timely regulatory submission of periodic safety reports
Supports the Drug Safety Physician in preparing various filing and submission documents for regulatory bodies, as required
Candidate Requirements
University degree in life science (e.g., pharmacy, nursing, M.Sc., or Ph.D.) or equivalent education in a health-related field, with at least 10 years of experience in pharmacovigilance within the pharmaceutical industry
Exceptional medical writing skills and previous experience in drafting regulatory safety documents (e.g., DSURs, PBRERs/PSURs, Integrated Safety Summaries, and clinical study reports)
In-depth knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines (ICH guidelines, EU, FDA)
Excellent communication, interpersonal, and problem-solving capabilities
Strong organizational skills with the ability to manage multiple projects within tight timelines
Proficient communication in English, both verbally and in writing
Thorough understanding of MedDRA coding thesauri, SMQs, WHO drug dictionary, and SDGs
Strong analytical skills and attention to detail
Apply online using the form below. Only applications matching the job profile will be considered.