Job Overview
Assist with the overall Safety trackers / applications / tools 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.
Experience (Minimum Required)
- Experience in Safety trackers / applications / tools operations support role.
- Experience working on any validated document management systems.
- At least 2 years of experience with drug safety trackers / applications / tools / systems such as intake / SAE / ESR trackers / applications / tools (SharePoint, in house developed).
- Good working knowledge of Microsoft office tools.
- Safety System integration knowledge.
Summary Of Responsibilities
- PV systems expert responsible for leveraging a strong combination of business and technical knowledge.
- Conduct project specific configurations in Safety application / tools.
- Maintain and document trackers / applications / tools configuration based on initial requirements and any subsequent changes.
- Evaluate proposed project ideas /software changes through technical impact analysis and estimated business value to contribute to decision-making.
- Develop and document standard and ad hoc reports from the safety trackers / applications / tools.
- Support and educate end users and sponsors, if applicable.
- Collaborate with training team in development of safety trackers / applications / tools 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 trackers / applications / tools 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 trackers / applications / tools, as needed.
- Expertise in Ticket management, issue resolution and escalating trackers / applications / tools issues where applicable.
- Respond to mailbox queries.
- Vendor management.
- Train team members on technical and functional aspects.
- Completing work assignments to the highest quality standards, adhering to relevant SOPs, and keeping up to date with knowledge of current PV regulations.
- Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines.
- Monitor the mailbox for trackers / applications / tools failures to resolve in a timely manner.
- Subject matter expert, looking for ways to improve compliance, quality, and efficiency.
- Perform User Acceptance Testing and complete required documentation.
- Lead critical team projects, responsible for managing team's workload.
- 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.
- 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.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Ability to operate standard office equipment.
Preferred Qualifications Include
- Clinical background working with clinical systems.
- Good understanding of SQL programming language.
- Experience working with ticket support applications.
Physical Demands/Work Environment
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