Position Summary
This role requires working as part of the Safety & MI System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases.
Principal Responsibilities
The Safety System Administrator is primarily responsible for:
• 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
Principle Functions For the Client (may include but is not limited to the following)
• Set up and maintenance of project specific database libraries including:
o Products
o Licenses
o Studies
o 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.
For the Company (may include but is not limited to the following)
• 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
Other Supportive Responsibilities
Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV.
Educated to degree standard
Demonstrated work experience within Argus Safety Systems.
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.