The Safety Scientist plays a crucial 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 in safety data analysis and reviewing the product safety profile.
Providing expertise on global safety regulations and guidelines.
Safety Signal Tracking and Management
Acting as the Secretary of the Idorsia Drug Safety Committee (DSC) to evaluate the safety profiles of both investigational and marketed Idorsia compounds.
Assisting the Drug Safety Physician in the medical safety evaluation of identified safety signals and preparing responses to safety queries requested by health authorities.
Leading safety signal tracking and management, ensuring proper documentation and tracking of new safety signals, and overseeing timely completion of safety measures or actions.
Monitoring PRAC meeting documents and other relevant sources to inform the responsible Drug Safety Physician and the Head of GDS of any significant safety information related to Idorsia's products.
Periodic Safety Reporting and Medical Writing
Coordinating the planning schedule and allocation of responsibilities for regulatory aggregated periodic safety report preparation and submission to health authorities.
Collaborating closely with departments such as Drug Regulatory Affairs (DRA), Clinical Pharmacology, Clinical Science, and Global Medical Affairs to ensure accurate and timely contributions to periodic safety reports.
Acting as the lead author in collaboration with the responsible Drug Safety Physician for the medical writing of periodic safety reports and ad-hoc safety analysis reports.
Participating in the review of medical and scientific literature relevant for inclusion in periodic safety reports.
Working with DRA to ensure timely regulatory submission of periodic safety reports.
Supporting the Drug Safety Physician in preparing additional filing and submission documents for regulatory bodies, including ISS, the Reference Safety Information (RSI) section of the Investigator Brochure (IB), and EU Risk Management Plans (RMP), as required.
Candidate Requirements
A 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 in the pharmaceutical industry.
Excellent medical writing skills with prior experience in drafting regulatory safety documents (e.g., DSURs, PBRERs/PSURs, and/or Integrated Safety Summary (ISS) reports, clinical study reports, etc.).
Solid 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 capabilities with the ability to meet tight deadlines through effective project management.
Proficient communication skills in English, both verbal and written.
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.