Safety Systems Specialist II, PSS

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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Originally posted on Himalayas