Description
Vigilance is essential to guarantee the ongoing understanding of the profile of adverse events related to the use of RB medicinal products, medical devices, vitamins, minerals and supplements (VMS) and cosmetics.This role is a crucial role since the post-holder is responsible for completing the key tasks in the provision of safety services and vigilance to facilitate and support the ongoing marketing of RB medicinal products, medical devices, vitamins, minerals and supplements (VMS) and cosmetics.
The safety function is a statutory function imposed by external regulators.
- Safety Database and Information Officer is accountable overall to the Global Vigilance Manager and finally to the EU QPPV.
- Safety Database and Information Officer is directly accountable to, on a day to day basis, to the Team Leader.
- Safety Database and Information Officer is responsible for the accurate and efficient completion of the tasks leading to the complete management of vigilance.
Specific tasks and responsibilities include, but are not limited to:
- Administration of the Vigilance safety database system
- Incidents management and troubleshooting issues
- Change Management ensuring changes to the system are correctly documented through change control and governance complying with Project Methodology and ensure computer system validation requirements are met
- Creation and execution of test scripts for ongoing database activities and change controls
- Management and monitoring of interfaces including Axway Gateway
- Develop SQL queries and search templates
- Project work and setup - examples include, management of set-up of new Authorities on safety database for inbound or outbound electronic reporting
- Management of all associated SOPs
- Ensure all members of Global Vigilance Group and third party case processors are appropriately trained
- Co-ordination and management of dictionary upgrades
- Vendor management and escalation of issues/queries as necessary
- Managing Global Electroning System for Change control and CAPA management for Vigilance processes
- Managing EVMPD and Eudravigilance administration activities
- Dealing with competent authorities regarding queries relating to safety database administration and reporting matrix
- Working with all teams to ensure the system is continually fit for purpose.
- Assisting when required in case entry and reporting.
- Assisting when required in MedDRA coding reviews.
Scope:
Safety Database and Information Officer is responsible for vigilance management of reports of adverse events related to RB's medicinal products, medical devices, vitamins, minerals and supplements (VMS) and cosmetics.
This role will be responsible for all aspects of business system administration and maintenance of the Global Vigilance Group's safety system, including data maintenance, SQL reports, minor configurations, user administration and change management.
Safety Database and Information Officer is responsible for supporting local Drug Safety Officers in operating countries and for management of safety electronic records and databases.
Safety Database and Information Officer will focus on parts of the safety reporting overall process in direction from line management and the manager of the Global Vigilance Group. Focus is allocated subject to business needs at the discretion of the manager.
Safety Database and Information Officer will manage data activity for the vigilance system the discretion of the manager. This will not be limited to database activity.
Experience in developing SQL queries is not essential as you can be trained in this area but experience with coding is required.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales