Job Overview:
- Assist with the overall Safety system implementation, support, configuration, and migration related activities.
- Responsible for providing 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 an appropriate quality of service in a safe and cost-effective manner.
- Provide supervision and day-to-day management of projects, ensuring quality, compliance, and timely delivery.
- Candidate will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.
Summary of Responsibilities:
The statements below are intended to describe the job’s general nature and not to be an exhaustive list of all responsibilities, skills, and duties.
- PV systems expert responsible for leveraging a strong combination of business and technical knowledge.
- Conduct and oversee project specific configurations in safety systems.
- 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, as applicable.
- Collaborate with training team in development of safety system specific training modules.
- 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).
- Actively participate in and oversee data migration activities and documentation related to migration.
- Expertise in Ticket management, issue resolution and escalating system issues where applicable.
- Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines.
- Monitor the mailbox for system failures to resolve them promptly and manage vendor queries.
- Subject matter expert, looking for ways to improve compliance, quality, and efficiency.
- Perform and review User Acceptance Testing and complete required documentation.
- Lead critical team projects and are responsible for project deliverables within budget.
- Monitor staff project quality, timelines, and budgets to foresee and correct issues and assure project expectations are met.
- Effectively communicate the status of projects to line management and project managers.
- Carry out team development responsibilities including mentoring, and administrative activities.
- Support to new hires, onboarding, transfers, and contractors, in coordination with the reporting manager.
- Representing the Systems team at internal project team meetings, client meetings and audits.
- Contribute to the ongoing improvement of programming processes, methodology and documentation.
- Collaborate closely with key stakeholders including follow-up on vendor deliverables and service according to agreements.
- 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.
- Experience in systems operations support role.
- Experience working on any validated document management systems.
- Good working knowledge of Microsoft office tools.
- System integration knowledge.
- Required Skills – Project Management, Change Management, Customer Relationship Management (CRM), and Vendor Management.
Experience (Minimum Required):
- 6+ years of experience in drug safety systems such as Argus/ARISg/Veeva, with a minimum of 2 years of project management experience.
- Good team player and offer peer support as needed.
- Ability to set priorities and handle multiple tasks.
- 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 to have.
- Good understanding of SQL programming language – Good to have.
- Experience working with ticket support applications.
Physical Demands / Work Environment:
Office/Home-Based:
Work Environment:
o Work is performed in an office environment with exposure to electrical office equipment.
o Occasional drives to site locations with occasional travel both domestic and international.
Physical Requirements:
o Frequently stationary for 6-8 hours per day.
o Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
o Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
o Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
o Light to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum lift of 15-20 lbs.
o Regular and consistent attendance.
o Varied hours may be required.
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