Senior Safety System Specialist

Job Overview:
Assist with the overall Safety system implementation, support, configuration, and migration related activities. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible for providing all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. Expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual

Summary of Responsibilities:

- PV systems team member responsible for leveraging a strong combination of business and technical knowledge.

- Conduct project specific configurations in Safety systems.

- Maintain and document system configuration based on initial requirements and any subsequent changes.

- Develop and document standard and ad hoc reports from the safety systems.

- Support and educate end users and sponsors, if applicable.

- Collaborate with training team in development of safety system specific training module.

- Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure requirements are delivered on time and in collaboration with Tech partner.

- Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ).

- Conduct routine and ad hoc data extraction (i.e. PSURs, DSURs, 6-monthly listings).

- Actively participate in all data migration activities and documentation related to migration.

- Support with change management and training of the systems, as needed.

- Expertise in Ticket management, issue resolution and escalating system issues where applicable.

- Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines.

- Subject matter expert, looking for ways to improve compliance, quality and efficiency.

- Respond to mailbox queries.

- Completing work assignments to the highest quality standards, adhering to relevant SOPs and keeping up to date with knowledge of current PV regulations.

- Perform User Acceptance Testing and complete required documentation.

- Collaborate with training team in development of safety system specific training module.

- Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ).

- Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure requirements are delivered on time and in collaboration with Tech partner.

- Any other duties as assigned by management.

- And all other duties as needed or assigned.

Qualifications (Minimum Required):

- Life Science or IT/computing degree.

- Fortrea may consider relevant and equivalent experience 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 (Minimum Required):

- Experience in systems operations support role.

- Experience working on any validated document management.

- Good keyboard skills, preferably with knowledge of MS office and Windows.

- Ability to operate standard office equipment.

Preferred Qualifications Include:

- Life Science or IT/computing degree

- Clinical background working with clinical systems.

- Good understanding of SQL programming language.

- Good Team player and offer 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.

Physical Demands/Work Environment:

- Office Environment or remote.

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