Safety Surveillance Scientist

• Ensure compliance with global and local procedural documents, implementing Patient Safety objectives, policies, and processes
• Assist physicians in maintaining updated knowledge of assigned products, focusing on safety perspectives such as pharmacology, indications, efficacy, and potential clinical studies
• Review surveillance strategy document and confirm understanding of changes
• Assess aggregate case reports from designated safety database using relevant IS systems
• Review and evaluate literature bulletins and published meeting abstracts according to search strategy, utilizing relevant IS systems
• Identify safety signals from routine review of cumulative safety data, conduct initial evaluation, and document outcomes based on specified criteria
• Document potential signals and related information in the signal tracking tool, maintaining surveillance action log
• Notify surveillance team of any safety signals requiring urgent evaluation and action
• Conduct further evaluation of safety signals as required, utilizing designated databases and published literature
• Prepare, summarize, evaluate, and document routine pre-SERM safety outputs from databases, FDA AERS, WHO Vigibase, and published literature
• Participate in routine and ad-hoc team and project meetings, including Handover, Surveillance, and Safety Management Team Meetings
• Participate in conducting gap analysis and identifying remedial actions for improving deliverable quality
• Provide regular work updates to lead-safety surveillance

• Degree in life science or related field
• Familiarity with drug safety and clinical development, including proficiency in ICH/GCP principles
• Strong knowledge of pharmacovigilance practices, particularly in signal detection and evaluation
• Understanding of global Pharmacovigilance regulatory requirements
• Excellent written and verbal communication skills for effective presentation and critical discussion of clinical data internally and externally
• Ability to evaluate, interpret, and synthesize scientific data, demonstrating analytical thinking capabilities
• Proficiency in English, with fluency in written and verbal communication

Profession