Clinical Safety System Administrator

Summary

Join PrimeVigilance, a global leader in pharmacovigilance, as a Safety System Administrator. Maintain and support database systems, including Argus Safety Systems. Your responsibilities will encompass database administration, user training, data migration, and system validation. You will work with internal and client teams, generating reports and ensuring data quality. The role requires a degree and demonstrated experience with Argus Safety Systems. PrimeVigilance offers training, career development, and a supportive work environment.

Requirements

• Educated to degree standard
• Demonstrated work experience within Argus Safety Systems

Responsibilities

• Maintenance of database libraries
• Involvement in system validation activities
• Interrogating the database and generating outputs for internal and client use
• Training and providing database access to internal and client users
• Set up and maintenance of project specific database libraries including: Products, Licenses, Studies, Reporting destinations
• Documenting and validating any change to the project specific database
• Support during legacy data transfer e.g., validation
• Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation)
• Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required
• Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed)
• Provide database training to clients
• Providing and documenting client / internal team access upon receipt of an approved access request
• Coordinate user access (including maintenance and revoking access)
• Maintain database procedures including core data handling conventions
• Provide database training and certification to PrimeVigilance users
• Provide user support
• Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures
• Provide case processing quality and compliance metrics to the Quality Team
• Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc
• Execute business continuity periodic testing for database failure
• Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required
• Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required
• Assist PrimeVigilance senior management on an as needed basis
• Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language