Safety System Administrator (Required Argus Safety Systems, system configuration
Ergomed
IndiaremotePosted 13 days ago
Skill Required
Safety-System-AdministratorDatabase-AdministratorPharmacovigilance-Database-AdministratorArgus-Safety-AdministratorIT-AdministratorSafety-Systems-SpecialistSystems-AdministratorSystems AdministratortroubleshootingTestNGRustandGoFulltime
Key highlights
- Required experience: Argus Safety Systems
- Education: Degree standard
Role overview
This role requires working as part of the Safety & MI System Administrator Team performing database administration activities, supporting the creation and upgrade of database instances, change control, data migration, first line user support, and user training. As a global pharmacovigilance specialist, PrimeVigilance focuses on helping clients navigate complex regulations while keeping patient safety at the center of every decision.
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
Requirements
- Educated to degree standard
- Demonstrated work experience within Argus Safety Systems
Benefits
- Environment built on kindness, flexibility, growth and belonging
Additional details
- Part of the Ergomed Group
- Company values: Quality, Integrity and trust, Drive and passion, Agility and responsiveness, Belonging, Collaborative partnerships
- Global reach across Europe, North America, South America, Asia and Australia
- Originally posted on Himalayas