Medicinal Product Safety Scientist

Key Responsibilities

The Safety Scientist is a pivotal role for 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 safety data analysis and review of the product safety profile
• Providing expertise on global safety regulations and guidelines

Safety Signal Tracking and Management:

• Acts as Secretary of Idorsia Drug Safety Committee (DSC) evaluating safety profile of investigational and marketed compounds
• Supports Drug Safety Physician in medical safety evaluation of identified safety signals and safety query responses to Health Authorities
• Leads safety signal tracking and management, ensuring proper documentation, oversight, and timely completion of safety measures
• Monitors PRAC meeting documents and other relevant sources to inform the responsible Drug Safety Physician and Head of GDS of relevant safety information

Periodic Safety Reporting and Medical Writing:

• Coordinates planning, scheduling, and allocation of responsibilities for regulatory periodic safety report preparation and submission
• Collaborates with other departments (Drug Regulatory Affairs, Clinical Pharmacology, Clinical Science, Global Medical Affairs) to ensure accurate and timely contributions
• Acts as lead author cooperating with Drug Safety Physician in medical writing of periodic safety reports and ad-hoc safety analysis
• Reviews medical/scientific literature relevant for inclusion in periodic safety reports
• Collaborates with DRA colleagues to ensure timely regulatory submissions
• Supports Drug Safety Physician in preparation of other regulatory filing documents (e.g., ISS, RSI, EU Risk Management Plan)

Candidate Requirements

• University degree in life science (e.g., pharmacy, nursing, M.Sc., or Ph.D.) or equivalent in health-related field with at least 10 years pharmacovigilance experience in pharmaceutical industry
• Excellent medical writing skills with experience writing regulatory safety documents (DSURs, PBRERs/PSURs, ISS, clinical study reports)
• Solid knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines (ICH, EU, FDA)
• Excellent communication, interpersonal, and problem-solving skills
• Strong organizational and project management skills, able to meet tight timelines
• Effective communication in English, verbal and written
• Excellent knowledge of MedDRA coding thesauri and SMQs, WHO drug dictionary and SDGs
• Strong analytical skills with attention to detail