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 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 product safety profiles
• Providing expertise on global safety regulations and guidelines

Safety Signal Tracking and Management

• Acting as the Secretary of Idorsia's Drug Safety Committee (DSC), evaluating the safety profile of both investigational and marketed 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 to ensure that newly identified safety signals are accurately documented and overseen, with actions taken in a timely manner
• Monitoring PRAC meeting documents and relevant information sources, and informing the responsible Drug Safety Physician and the Head of Global Drug Safety of any essential safety updates for 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
• Working closely with various departments (e.g., Drug Regulatory Affairs (DRA), Clinical Pharmacology, Clinical Science, 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 in the medical writing of periodic safety reports and ad-hoc safety analysis reports
• Participating in the review of medical and scientific literature for inclusion in periodic safety reports
• Collaborating with colleagues in DRA for the timely regulatory submission of periodic safety reports
• Assisting the Drug Safety Physician in the preparation of various filing and submission documents to regulatory bodies, such as the ISS, Reference Safety Information (RSI) section of the Investigator Brochure (IB), and the EU Risk Management Plan (RMP)

Candidate Requirements

• University degree in life sciences (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 within the pharmaceutical industry
• Excellent medical writing skills and prior experience in drafting regulatory safety documents (e.g., DSURs, PBRERs/PSURs, Integrated Safety Summary (ISS), clinical study reports)
• Solid understanding of clinical trial and post-marketing regulatory safety regulations and guidelines (ICH guidelines, EU, FDA)
• Outstanding communication, interpersonal, and problem-solving skills
• Strong organizational capabilities and the ability to meet tight deadlines with effective project management
• Proficient communication skills in English, both verbal and written
• Comprehensive knowledge of MedDRA coding thesauri, SMQs, and the WHO drug dictionary
• Strong analytical skills with meticulous attention to detail

Apply online using the form below. Please note that only applications matching the job profile will be considered.