Global Patient Safety Scientist

🌐 Overview

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. You’ll work across all phases of development, supporting safety data evaluation, risk assessments, and compliance with international pharmacovigilance regulations.

🛠️ Responsibilities

• Conduct scientific review of safety data for aggregate reports (e.g., DSURs, PSURs, RMPs)
• Perform signal detection, evaluation, and risk assessment activities
• Support safety surveillance throughout clinical trials (Phases I–IV), including review of SAEs, AESIs, TEAEs
• Provide input into protocols, study reports, and clinical safety documentation
• Collaborate with cross-functional teams (Regulatory, Clinical Development, Medical Affairs, QA, etc.)
• Contribute to responses for health authority inquiries and safety-related submissions
• Liaise with vendors, CROs, and partners to ensure accurate, timely safety data handling
• Ensure SAE reconciliation between safety databases and clinical trial systems
• Monitor and interpret global pharmacovigilance regulatory changes and contribute to SOP updates
• Support safety oversight for Market Research and Patient Support Programs

✅ Key Requirements

• Degree in a bioscience-related field (BSc, PharmD, MD)
• Fluency in English (written and spoken)
• Awareness of global pre- and post-marketing PV legislation
• Experience preparing or contributing to DSURs, PSURs, RMPs, or safety responses
• Understanding of pharmacovigilance responsibilities in clinical trials and post-marketing settings
• Familiarity with safety data related to organ toxicities is a plus
• Experience with regulatory submissions (NDA/BLA) or work within a regulatory agency is advantageous