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 writing (DSUR, PBRER), •supporting the Drug Safety Physician in the safety data analysis and review of the product safety profile and •providing expertise on global safety regulations and guidelines,

Safety Signal Tracking and Management: •Acts as the Secretary of Idorsia Drug Safety Committee (DSC) evaluating the safety profile of Idorsia compounds (investigational and marketed) •Supports Drug Safety Physician in the medical safety evaluation of identified safety signals and preparation of responses to safety queries requested by HAs. •Acts as the safety signal tracking and management lead ensuring that new safety signals identified are properly tracked and documented ensuring oversight on the signal activities and timely completion of safety measures or actions as determined. •Monitors PRAC meeting documents or any other relevant sources and informs the responsible Drug Safety Physician and the Head of GDS of any relevant safety information for products of interest for Idorsia (e.g., same class, competitors).

Periodic Safety Reporting and Medical Writing: •Coordinates the planning schedule and allocation of responsibilities for regulatory aggregated periodic safety reports preparation and submission to HAs. •Work closely with other departments/functions (e.g., Drug Regulatory Affairs (DRA), Clinical Pharmacology, Clinical Science, Global Medical Affairs) involved in the preparation of aggregated periodic safety reports to ensure that their contribution is accurate and provided in a timely fashion. •Acts as the lead author in close cooperation with the responsible Drug Safety Physician in the medical writing of periodic safety reports or other ad-hoc safety analysis reports. •Participates in the review of medical/scientific literature relevant for inclusion in periodic safety reports. •Collaborates with colleagues in DRA to ensure timely regulatory submission of periodic safety reports. •Support the Drug Safety Physician in the preparation of other types of filing and submission documents to Regulatory bodies e.g., ISS, Reference Safety Information (RSI) section of Investigator Brochure (IB), EU Risk Management Plan (RMP) etc., as required.

Candidate Requirements

•University degree in life science (e.g., pharmacy, nursing, M.Sc., or Ph.D.) or equivalent education in health-related field with at least 10 years of experience in pharmacovigilance in the pharmaceutical industry. •Excellent medical writing skills and previous experience in writing regulatory safety documents (e.g., DSURs, PBRERs/PSURs, and/or Integrated Safety Summary (ISS), clinical study reports etc.). •Solid knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines (ICH guidelines, European Union [EU], FDA [US]). •Excellent communication, interpersonal and problem-solving skills. •Strong organizational skills and ability to work within tight timelines with effective project management skills. •Effective communication in English (both verbally and in writing). •Excellent knowledge of MedDRA coding thesauri and SMQs and WHO drug dictionary and SDGs. •Strong analytical skills with attention to details.