Safety Systems Specialist

• Perform database-related activities, including configuration management, issue resolution, and data migrations
• Provide technical expertise on pharmacovigilance systems, particularly Argus Safety
• Plan and support system validation
• Support and maintain the overall safety system and electronic reporting to health authorities
• Serve as subject matter expert for Argus 8.x Oracle Cloud and integrations such as OAS and Axway
• Lead project kick-offs for client enterprise creation, validation, and configuration
• Gather functional and technical requirements
• Provide configuration solutions for client case processing and reporting
• Support configuration and validation of the Argus MASTER tenant
• Identify database requirements and develop and implement efficiency and quality solutions
• Present solutions to management
• Support safety database and associated system upgrades and patches, including planning, testing, and implementation
• Support client data transfers, imports, exports, and data migrations
• Develop, validate, and implement standard and custom reports
• Query databases to support inspections
• Manage and escalate system issues with pharmacovigilance software vendors
• Author system work instructions, standard operating procedures, and associated forms
• Maintain professional and technical knowledge through continuing education
• Accept project assignments delegated by senior staff
• Develop staff knowledge through mentoring, classroom training, and user workshops
• Ensure compliance with company policies and procedures

• Bachelor's degree in Information Technology or related experience
• Demonstrated knowledge and experience with pharmacovigilance systems in a pharmaceutical company, biotech, or CRO
• Demonstrated knowledge and experience supporting Oracle Argus Safety system and application integrations such as OAS and Axway
• Understanding of pharmacovigilance processes and ability to translate them into technical solutions
• Proficient in SQL and/or PL/SQL
• Experience with system validation and compliance with global regulations
• Excellent people and project management skills
• Excellent prioritization, analytical, problem-solving, multitasking, oral, and written communication skills
• Ability to work within a global Safety and MI team

• Remote work option
• Continuing education through workshops, reviewing professional publications, and participating in professional organizations
• Individual mentoring, classroom trainings, and user workshops
• Collaborative and supportive global team environment
• Growth and professional development opportunities
• Belonging-focused workplace culture
• Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting