Job Title

OverviewAll potential candidates should read through the following details of this job with care before making an application. We are seeking a scientifically driven and highly organized Safety Scientist to join a Global Patient Safety (GPS) team. This role plays a critical part in supporting the safety surveillance of clinical and post-marketing programs, contributing to signal management, regulatory documentation, and cross-functional collaboration. Youll work across all phases of development, supporting safety data evaluation, risk assessments, and compliance with international pharmacovigilance regulations. ResponsibilitiesConduct scientific review of safety data for aggregate reports (e.g., DSURs, PSURs, RMPs)Perform signal detection, evaluation, and risk assessment activitiesSupport safety surveillance throughout clinical trials (Phases IIV), including review of SAEs, AESIs, TEAEsProvide input into protocols, study reports, and clinical safety documentationCollaborate with cross-functional teams (Regulatory, Clinical Development, Medical Affairs, QA, etc.)Contribute to responses for health authority inquiries and safety-related submissionsLiaise with vendors, CROs, and partners to ensure accurate, timely safety data handlingEnsure SAE reconciliation between safety databases and clinical trial systemsMonitor and interpret global pharmacovigilance regulatory changes and contribute to SOP updatesSupport safety oversight for Market Research and Patient Support Programs Key RequirementsDegree in a bioscience-related field (BSc, PharmD, MD)Fluency in English (written and spoken)Awareness of global pre- and post-marketing PV legislationExperience preparing or contributing to DSURs, PSURs, RMPs, or safety responsesUnderstanding of pharmacovigilance responsibilities in clinical trials and post-marketing settingsFamiliarity with safety data related to organ toxicities is a plusExperience with regulatory submissions (NDA/BLA) or work within a regulatory agency is advantageous