Drug Safety Officer

• Handle serious adverse events in clinical trials and spontaneous market reports
• Collect, assess, and enter safety cases into the safety database
• Review and approve processed cases and perform AE/SAE reconciliation
• Code adverse events, medical history, and concomitant medication using MedDRA and WHO-Drug Dictionary
• Perform quality control and approve safety coding
• Review and write safety sections for clinical study protocols
• Review clinical trial reports and investigator brochures from a safety perspective
• Write safety sections for PSUR/PBRER, DSURs, IND, NDA, and other safety documents
• Conduct literature searches
• Perform electronic reporting to EudraVigilance
• Contribute to post-approval surveillance plans, instructions, and SOPs
• Update safety-handling templates for studies and projects
• Act as Project Lead for safety-only projects when required
• Participate in relevant meetings and communicate information to department and study team members
• Provide internal support to relevant departments
• Participate in process improvement projects
• Contribute to developing routines that enhance work at TFS
• Validate department-specific computer applications for drug safety requirements
• Stay updated on laws, directives, and guidelines related to safety reporting and pharmacovigilance
• Educate and supervise new Drug Safety personnel
• Participate in marketing activities

• 5 years of relevant experience
• Ability to work in a fast-paced environment with changing priorities
• Understanding of medical terminology and science associated with assigned drugs and therapeutic areas
• Understanding of Good Clinical Practice regulations, ICH guidelines, pharmacovigilance legislation, and internal SOPs
• Ability to work independently and in a team matrix organization with little or no supervision
• Excellent written and verbal communication skills
• Proficiency using typical word processing software
• Spreadsheet skills desirable
• Presentation software knowledge a plus

• Competitive compensation package
• Comprehensive benefits
• Opportunity for personal and professional growth
• Collaborative and innovative work environment
• Equal opportunity employment for candidates based in Spain, including people with disabilities