Job title: Safety System Administrator
Company: PrimeVigilance
Job description: Company Description
PrimeVigilance, an Ergomed brand , was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects.
PrimeVigilance is continuing to expand and is looking for a Project Services Manager to join the team in the Guildford office. This is a newly created role that will be assigned to internal business improvement initiatives. This role will address project management, business analysis and computer system validation, creating all necessary project documentation with input from business and IT representatives.
Job Description
Position Summary
This role requires working as part of the Safety 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.
Qualifications
Educated to degree standard or appropriate equivalent work experience.
Additional Information
Line Management:
The Safety System Administrator will report to the Senior Safety Systems Specialist, Safety & Information Systems
Expected salary:
Location: Mumbai, Maharashtra
Job date: Sat, 15 Oct 2022 22:10:29 GMT
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