Job Title: Safety Systems Specialist
Job Overview:
The Safety Systems Specialist will assist with the implementation, support, configuration, and migration of safety systems. This role provides services to clients either as part of project support or as a standalone function, ensuring the delivery of high-quality, safe, and cost-effective solutions. The role requires adherence to the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3, as outlined in the company’s Health and Safety Manual.
Qualifications (Minimum Required):
Degree in Life Sciences or IT/Computing. Fortrea may consider relevant experience in lieu of formal education.
Minimum of 3 years’ experience with drug safety systems such as Argus, ARISg, Veeva, or equivalent.
Strong working knowledge of Microsoft Office tools.
Experience with system integration.
Preferred Qualifications:
Clinical background with experience in clinical systems.
Knowledge of SQL programming.
Strong team player with the ability to provide peer support.
Ability to prioritize tasks and manage multiple responsibilities.
Strong attention to detail.
Excellent written and verbal communication skills.
Logical mindset with aptitude for handling and proofreading numerical data.
Summary of Responsibilities:
Serve as a key member of the PV systems team, leveraging business and technical expertise.
Conduct project-specific configurations within safety systems.
Maintain and document system configurations based on initial and evolving requirements.
Develop and document standard and ad hoc reports from safety systems.
Support and educate end-users and sponsors as needed.
Collaborate with the training team to develop safety system-specific training modules.
Engage with business stakeholders to understand requirements, document user needs, and ensure timely delivery in collaboration with technical partners.
Provide guidance on standard safety systems front-end reporting, including advanced conditions and Standard MedDRA Queries (SMQ).
Conduct routine and ad hoc data extractions (e.g., PSURs, DSURs, six-monthly listings).
Participate actively in data migration activities and related documentation.
Support change management and training initiatives for safety systems.
Manage ticketing, resolve issues, and escalate system problems as appropriate.
Update departmental SOPs, working practices, and guidelines.
Act as a subject matter expert, recommending improvements to compliance, quality, and efficiency.
Respond to mailbox queries and complete work assignments according to SOPs and current PV regulations.
Perform User Acceptance Testing (UAT) and complete associated documentation.
Any other duties as assigned by management.
Experience (Minimum Required):
Experience in system operations support roles.
Experience with validated document management systems.
Proficient keyboard skills, ideally with MS Office and Windows.
Ability to operate standard office equipment.
Physical Demands / Work Environment:
Office-based or remote work environment.
EEO & Accommodations:
Learn more about our Equal Employment Opportunity and Accommodations policies [here].
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