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.
Summary of Responsibilities:
- PV systems expert 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.
- 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 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.
- 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 system 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.
Experience (Minimum Required):
- Experience in systems operations support role.
- Experience working on any validated document management systems.
- At least 4 years of experience with drug safety systems such as Argus/ARISg/Veeva.
- Good working knowledge of Microsoft office tools.
- System integration knowledge.
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:
- Office environment or remote.
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