Job Purpose:
Provide safety technology support to internal and external safety users and analysts, including the analysis of problems, through to the implementation of solutions. Participates in initiatives in the administration, integration, implementation, validation, software updates, bug fixes, change requests, oversight management and/or application support for assigned systems and technology. Ensure that all applicable documentation is complete and in accordance with corporate policy and guidelines. Utilize core operational understanding to identify system/process/analysis improvements.

Key Accountabilities:

Accountability: Technology Support

• 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 were 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.
  

Accountability: Organizational Representation

• 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.
  

Accountability: Issue Management

• Collaborate with Parexel IT, vendor, Parexel Safety Services staff, and clients for the proper analysis, resolution, and closure of issues for supported systems.
  

Accountability: Team Support

• Provide support to new or developing staff in the systems and activities necessary for the fulfillment of their job responsibilities.
  

Accountability: Change Management

• 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.
  

Skills:

• 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.
  

Knowledge and Experience:

• Area: Safety Supportive Applications (Argus, Vault Safety, EDC, Safety ERP) - 2+ years of experience in all functional areas of chosen safety technology including all secondary tools and processes.

• Area: Safety Business Processes - 2+ years of experience working closely with operational teams to manage issues, gather and document requirements, and deliver solutions.

• Area: Peer oversight, coaching, training - Experience of supporting team members.

• Area: Propose and Deliver System/Process Improvements - Demonstratable participation in improvement initiatives.

• Area: System Validation Activities - Experience of computerized system methodologies and processes.

• Area: Communication Skills - Fluent in English; demonstrated ability to write technical documentation and deliver clear presentations to stakeholders.

• Area: Leadership Representation - Demonstratable experience working with cross-functional teams as a safety technology representative.
  

Education:

Bachelor’s degree in engineering/computer science, master's or equivalent preferred.