Safety Systems Specialist

The Safety Systems Specialist will work as part of the Safety & MI Systems team and will be responsible for database related activities including configuration management, issue resolutions, data migrations requiring strong SQL developer skills, for providing technical expertise on pharmacovigilance systems, specifically the Argus Safety database, including planning and validation. The role is critical to pharmacovigilance to support and maintain the overall safety system, electronic reporting to health authorities and ensuring compliance to the relevant regulatory requirements, policies and standards.

• Serves as subject matter expert for pharmacovigilance systems (Argus 8.x Oracle Cloud) and associated application integrations (eg OAS, Axway)
• Lead project kick-off for client enterprise creation, validation and configuration. Gather functional and technical requirements. Provide configuration solutions to support client case processing and reporting.
• Support configuration/validation of the Argus MASTER tenant enterprise used for client enterprise creation.
• Proactively identifies database requirements to maximize efficiency and quality of end user performance; takes initiative to investigate, develop and implement solutions. Proactively presents solutions to management.
• Support safety database and associated systems upgrades/patches for the IT team, including project planning, testing and implementation.
• Support client data transfers (data imports and exports), SQL developer skills required, including prior experience in data migrations.
• Support development, validation and implementation of standard and custom reports within company reporting tools. Query database to support inspections as required.
• Manage and escalate system issues with the pharmacovigilance software vendors as needed.
• Assist with authoring pharmacovigilance system work instructions, standard operating procedures and associated forms.
• Maintains professional and technical knowledge through continuing education, such as workshops, reviewing professional publications, participating in professional organizations
• Accept project assignments as delegated by senior staff, as needed.
• Develops staff knowledge of the safety database through individual mentoring, classroom trainings, user workshops as needed
• Ensure compliance with relevant company policies and procedures.