Medicinal Product Safety Scientist / Medicinal Product Safety Scientistess

Key Responsibilities

The Safety Scientist plays a crucial role in the benefit-risk evaluation of Idorsia products. Your responsibilities will include:

• 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 Idorsia compounds
• Assist the Drug Safety Physician in the medical safety evaluation of identified safety signals and in preparing responses to safety queries from health authorities
• Lead safety signal tracking and management, ensuring proper documentation and oversight of newly identified safety signals, as well as timely completion of safety measures
• Monitor PRAC meeting documents and other relevant sources, keeping the responsible Drug Safety Physician and Head of GDS informed of safety information related to Idorsia products and competitors

Periodic Safety Reporting and Medical Writing

• Coordinate the planning schedule and allocation 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 timely and accurate contributions to the reports
• Act as the lead author in cooperation with the responsible Drug Safety Physician for the medical writing of periodic safety reports and ad-hoc safety analysis reports
• Participate in the review of medical and scientific literature relevant for inclusion in periodic safety reports
• Work with colleagues in Drug Regulatory Affairs to ensure the timely submission of periodic safety reports to regulatory authorities
• Support the Drug Safety Physician in preparing filing and submission documents for regulatory bodies, such as ISS, Reference Safety Information (RSI) sections of Investigator Brochures (IB), EU Risk Management Plans (RMP), etc.

Candidate Requirements

• University degree in a life science field (e.g., pharmacy, nursing, M.Sc., or Ph.D.) or equivalent health-related education, with a minimum of 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 Summaries (ISS), clinical study reports, etc.)
• Strong knowledge of clinical trial and post-marketing regulatory safety guidelines, including ICH, European Union (EU), and FDA (US) regulations
• Exceptional communication, interpersonal, and problem-solving skills
• Strong organizational skills and the ability to manage projects effectively within tight deadlines
• Proficiency in English, both verbal and written
• Thorough understanding of MedDRA coding thesauri, standard MedDRA queries (SMQs), and the WHO drug dictionary and safety data group (SDG)
• Strong analytical skills with keen attention to detail

Apply online using the form below. Only applications matching the job profile will be considered.