The Safety Scientist plays a crucial role in the benefit-risk evaluation of Idorsia's products by:
Leading signal management activities.
Planning and writing periodic safety reports (DSUR, PBRER).
Supporting the Drug Safety Physician in safety data analysis and the review of the product safety profile.
Providing expertise on global safety regulations and guidelines.
Safety Signal Tracking and Management
Serve as the Secretary of the Idorsia Drug Safety Committee (DSC), evaluating the safety profile of both investigational and marketed compounds.
Assist the Drug Safety Physician in the medical safety evaluation of identified safety signals and in preparing responses to safety queries requested by health authorities.
Lead the safety signal tracking and management process, ensuring proper documentation of new safety signals while overseeing signal activities and the timely completion of required safety measures.
Monitor PRAC meeting documents and other relevant sources, promptly informing the responsible Drug Safety Physician and the Head of Global Drug Safety of any pertinent safety information related to Idorsia products (e.g., in the same class or competitors).
Periodic Safety Reporting and Medical Writing
Coordinate the planning schedule and distribution of responsibilities for the preparation and submission of regulatory aggregated periodic safety reports to health authorities.
Collaborate closely with various departments/functions (e.g., Drug Regulatory Affairs, Clinical Pharmacology, Clinical Science, Global Medical Affairs) to ensure accuracy and timeliness in the preparation of aggregated periodic safety reports.
Act as the lead author in close collaboration with the designated Drug Safety Physician on the medical writing of periodic safety reports and other ad-hoc safety analysis reports.
Participate in the review of medical and scientific literature pertinent to periodic safety reports.
Work together with colleagues in Drug Regulatory Affairs to ensure the timely regulatory submission of periodic safety reports.
Assist the Drug Safety Physician in preparing other filing and submission documents for regulatory bodies (e.g., ISS, Reference Safety Information section of Investigator Brochure, EU Risk Management Plan) as required.
Candidate Requirements
A university degree in a life science (e.g., pharmacy, nursing, M.Sc., or Ph.D.) or equivalent education in a health-related field, with a minimum of 10 years of experience in pharmacovigilance within the pharmaceutical industry.
Excellent medical writing skills, with previous experience in composing regulatory safety documents (e.g., DSURs, PBRERs/PSURs, Integrated Safety Summary, clinical study reports).
Thorough understanding of clinical trial and post-marketing regulatory safety regulations and guidelines (ICH guidelines, European Union [EU], FDA [US]).
Exceptional communication, interpersonal, and problem-solving skills.
Strong organizational abilities, capable of working within tight timelines and managing projects effectively.
Fluency in English, both verbally and in writing.
Proficient in MedDRA coding thesauri, SMQs, WHO drug dictionary, and SDGs.
Strong analytical skills with keen attention to detail.
Application Process
Apply online using the form below. Only applications matching the job profile will be considered.