Senior Safety System Specialist

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.