other
Posted 2 days agoSafety Systems Specialist II, PSS
at Fortrea
GlobalRemote
Responsibilities
- Conduct project specific configurations in Safety systems.
- Maintain and document system configuration based on initial
- 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
- Conduct routine and ad hoc data extraction (i.e., PSURs, DSURs, 6-monthly listings).
- Train team members on technical and functional aspects.
- Monitor the mailbox for system failures to resolve in a timely manner.
- Perform User Acceptance Testing and complete required documentation.
- Lead critical team projects, responsible for managing team’s workload.
- PV systems expert responsible for leveraging a strong combination of business and technical knowledge.
Requirements
- Completing work assignments to the highest quality standards, adhering to relevant SOPs, and keeping up to date with knowledge of current PV regulations.
- Qualifications (Minimum Required): Life Science or IT/computing degree. Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements.
- Ability to set priorities and handle multiple tasks.
- 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.
- 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.