The Safety Scientist plays a crucial role in the benefit-risk evaluation of Idorsia products by:
Leading signal management activities
Planning and writing periodic safety reports (DSUR, PBRER)
Supporting the Drug Safety Physician in the analysis and review of safety data
Providing expertise on global safety regulations and guidelines
Safety Signal Tracking and Management
Acting as the Secretary of the Idorsia Drug Safety Committee (DSC), which evaluates the safety profile of Idorsia compounds (both investigational and marketed)
Supporting the Drug Safety Physician in the medical safety evaluation of identified safety signals and preparing responses to safety queries from health authorities
Leading safety signal tracking and management efforts, ensuring that newly identified signals are properly documented and monitored for timely completion of any necessary safety actions
Monitoring PRAC meeting documents and other relevant sources to keep the Drug Safety Physician and the Head of Global Drug Safety informed of pertinent safety information regarding Idorsia products
Periodic Safety Reporting and Medical Writing
Coordinating the planning schedule and allocation of responsibilities for the preparation and submission of regulatory aggregated periodic safety reports to health authorities
Collaborating closely with other departments (e.g., Drug Regulatory Affairs, Clinical Pharmacology, Clinical Science, Global Medical Affairs) to ensure accurate and timely contributions to periodic safety reports
Serving as the lead author in cooperation with the responsible Drug Safety Physician for the medical writing of periodic safety reports and other ad-hoc safety analysis reports
Participating in the review of medical and scientific literature for inclusion in periodic safety reports
Working alongside colleagues in Drug Regulatory Affairs to ensure timely regulatory submission of periodic safety reports
Assisting the Drug Safety Physician in preparing various regulatory submission documents such as ISS, Reference Safety Information sections of Investigator Brochures, and EU Risk Management Plans as needed
Candidate Requirements
A university degree in life sciences (e.g., pharmacy, nursing, M.Sc., Ph.D.) or an equivalent education in a health-related field with at least 10 years of experience in pharmacovigilance within the pharmaceutical industry
Excellent medical writing skills and prior experience in drafting regulatory safety documents (e.g., DSURs, PBRERs/PSURs, Integrated Safety Summary, clinical study reports)
In-depth knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines (including ICH guidelines, EU, and FDA)
Exceptional communication, interpersonal, and problem-solving skills
Strong organizational skills with the ability to work effectively under tight deadlines while managing multiple projects
Proficient in English, both verbally and in writing
Thorough understanding of MedDRA coding thesauri, SMQs, the WHO drug dictionary, and SDGs
Strong analytical abilities with meticulous attention to detail
Apply online using the form below. Only applications matching the job profile will be considered.