Senior Safety System Specialist

Overview

Support implementation, configuration, support and migration of the safety system, as a support function to client project groups or as a stand-alone service, in line with the Health and Safety at Work Act 1974, the COSHH regulations 1989 and EC Directives 1992/3.

What you'll do

• Conduct project-specific configurations in safety systems.
• Maintain and document system configuration based on initial requirements and subsequent changes.
• Develop and document standard and ad hoc reports from the safety systems.
• Support and educate end users and sponsors, where applicable.
• Collaborate with the training team to develop safety system-specific training modules.
• Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure they are delivered on time in collaboration with the tech partner.
• Provide overall guidance and strategize use of standard safety systems front-end reporting, including advanced conditions and Standard MedDRA Queries (SMQ).
• Conduct routine and ad hoc data extraction (e.g. PSURs, DSURs, 6-monthly listings).
• Actively participate in all data migration activities and related documentation.
• Support change management and training of the systems, as needed.
• Manage tickets, resolve issues and escalate system issues where applicable.
• Update departmental Standard Operating Procedures, working practices and guidelines.
• Act as subject matter expert, looking for ways to improve compliance, quality and efficiency.
• Respond to mailbox queries.
• Complete work assignments to the highest quality standards, adhering to relevant SOPs and keeping up to date with current PV regulations.
• Perform User Acceptance Testing and complete required documentation.
• Perform any other duties as assigned by management.

What you'll need

• Life Science or IT/computing degree; relevant and equivalent experience may be considered in lieu of educational requirements.
• At least 3 years of experience with drug safety systems such as Argus, ARISg, Veeva or equivalent.
• Good working knowledge of Microsoft Office tools.
• System integration knowledge.
• Experience in a systems operations support role.
• Experience working with any validated document management system.
• Good keyboard skills, preferably with knowledge of MS Office and Windows.
• Ability to operate standard office equipment.

Nice to have

• Life Science or IT/computing degree.
• Clinical background working with clinical systems.
• Good understanding of the SQL programming language.
• Good team player, offering peer support as needed.
• Ability to set priorities and handle multiple tasks.
• Attention to detail.
• Good written and verbal communication skills.
• Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical data.

Details

• Work environment: office or remote.