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ERGOMED is a global healthcare services group supporting biotechnology and pharmaceutical companies across the drug development lifecycle. Its businesses include Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, delivering clinical research organization services, pharmacovigilance and medical information support, and GxP auditing. The company works on oncology, rare disease, and other complex clinical trials, with operations spanning around 100 countries.
Safety System Administrator – Argus Safety | ERGOMED | India Remote
Administer and configure Argus Safety databases supporting PrimeVigilance’s global pharmacovigilance operations. The role covers data migration, validation, access management, user training, troubleshooting, compliance reporting, and system improvement.
Description
- Administer safety databases as part of the Safety and Medical Information System Administrator team
- Support the creation and upgrading of database instances
- Manage change control and safety data migration activities
- Provide first-line user support and resolve database issues
- Maintain shared and project-specific database libraries
- Contribute to system validation activities
- Query databases and produce outputs for internal teams and clients
- Train users and manage database access for internal and client users
- Configure and maintain products, licenses, studies, and reporting destinations
- Document and validate changes to project-specific databases
- Support validation of legacy data transfers
- Help develop project-specific data-handling guidelines
- Prepare line listings, tabulations, and database outputs for aggregate reporting, signal detection, reconciliation, and related activities
- Provide case-processing metrics for invoicing
- Coordinate, maintain, and revoke user access
- Maintain database procedures and core data-handling standards
- Deliver database training and certification to PrimeVigilance users
- Investigate database-related deviations and document corrective actions
- Provide quality and compliance metrics to the Quality Team
- Identify improvement opportunities through training, guideline updates, and user guides
- Conduct periodic business continuity tests for database failures
- Assess software defects, user requests, and regulatory changes, then implement and validate appropriate updates
- Support IT, database vendors, and technical colleagues with troubleshooting and software fixes or enhancements
- Assist senior management when required
- May provide chargeable Argus and LSSMV consulting and training to clients
Requirements
- Degree-level education
- Professional experience with Argus Safety Systems
- Experience configuring Argus Safety Systems
- Experience with safety data migration
- Database administration experience
- Experience creating and upgrading database instances
- Experience managing change control and data migration activities
- Experience providing first-line user support and troubleshooting
- Ability to train users on database systems
- Ability to perform system validation activities
- Ability to query databases and generate outputs
- Knowledge of database libraries, products, licenses, studies, and reporting destinations
- Ability to prepare line listings, tabulations, and database outputs
- Ability to manage, maintain, and revoke user access
- Ability to investigate the root causes of database-related deviations
- Knowledge of quality procedures and regulatory requirements
- Ability to conduct business continuity testing for database failures
Benefits
- Remote work from India
- Flexible working environment
- Professional growth opportunities
- Supportive, collaborative workplace culture
- Training and certification opportunities
- Potential chargeable consulting and training work involving Argus and LSSMV
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