Job description
Company Description
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
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
Demonstrated work experience within Argus Safety Systems.
Additional Information
Why PrimeVigilance?
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
We look forward to welcoming your application.
- 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
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
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