Safety Technology Specialist

Job Description:

• Conduct set-up and support activities associated with the Parexel safety database (and associated systems) including but not limited to:
• New study set-up
• Periodic report configuration and generation
• Ad-hoc report configuration and generation
• Expedited report rule configuration
• End-user support
• Provide support and contribute to the planning and delivery of the handover of the safety database from client to Parexel where contracted to take over the pharmacovigilance tasks for client projects
• Provide support and contribute to the planning and delivery of the handover of safety data from Parexel to client at the end of study/project as contracted 
• Contribute to the content of standard operating procedures and controlled documents that pertain to safety technology
• Support the delivery of integration solutions between Parexel safety technologies and other applications to drive operational excellence, enhanced service capabilities
• Represent Safety Technology Management with other Parexel groups (such as TQM, QA, IT) to ensure that database, hardware, network, security, quality, integration, support and project services associated with maintained systems are adequate and sufficiently managed
• Represent Safety Technology Management to external auditors and inspectors during the examination of safety technology
• Deliver presentations for the service delivery of Parexel safety technology solutions
• Collaborate with Parexel IT, vendor, Parexel Safety Services staff, and clients for the proper analysis, resolution, and closure of issues for supported system Provide support to new or developing staff in the systems and activities necessary for the fulfillment of their job responsibilities
• Support change management in accordance with the Software Development Life Cycle through the ownership of activities including impact assessments, testing methodologies, and qualification.
• Support execution of tasks for software updates, change requests and application support for the supported applications
• Support the implementation of technology solutions for Safety Services for the purposes of business process optimization and improvement
• Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standards

Qualifications:

• BA/BSc Engineering/Computer Science, Masters or equivalent preferred-

• Good interpersonal, verbal, and written communication skills
• Client focused approach to work
• Good analytical and problem-solving skills 
• Good organizational and customer service skills
• Willingness to work in a matrix environment and to value the importance of teamwork
• Provide support and contribute to a team working through problem management
• Under instruction, take ownership of core tasks related to the support and maintenance of safety technologies
• Intermediate System Administration and application support skills within pharmacovigilance safety technology, including at least one of: safety databases, gateway / E2B, report development, signal detection.
• Interest in emerging pharmacovigilance safety technology, including AI
• Intermediate skills in using standard scripting languages e.g. SQL
• Experience of industry standard Service Desk Tools
• Intermediate technical writing capability
• Experience of standard SDLC processes including change management
• Experience of Agile methodology
• A flexible attitude with respect to work assignments and new learning
• Complete multiple and varied tasks with enthusiasm and prioritize workload using standard Project Management methodologies
• Experience of system validation and change management
• Intermediate knowledge of computer system regulations and guidance in the pharmaceutical industry including: 21 CFR Part 11, EMA Annex 11, GAMP
• Intermediate knowledge of Pharmacovigilance roles, standards and practices
• Intermediate knowledge of GVP and GCP