PrimeVigilance Hiring for Associate Safety System Administrator at Mumbai, Maharashtra Full Time

Full Job DescriptionCompany 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 Associate Safety System Administrator is primarily responsible for:
Maintenance of database librariesInvolvement in system validation activitiesInterrogating the database and generating outputs for internal and client useTraining and providing database 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 databaseSupport during legacy data transfer e.g., validationSupporting/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 requiredProvide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed)Provide database training to clientsProviding 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 conventionsProvide database training and certification to PrimeVigilance usersProvide user supportInvolvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality proceduresProvide case processing quality and compliance metrics to the Quality TeamIdentify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc.Execute business continuity periodic testing for database failureEnsure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as requiredSupport 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 Associate Safety System Administrator will report to the Senior Safety Systems Specialist, Safety & Information Systems