Provide specialized safety technology support and leadership to internal and external safety users and analysts, including the analysis of complex problems, through to the implementation of solutions. Drive initiatives in the administration, integration, implementation, validation, software updates, bug fixes, change requests, oversight management and/or application support for assigned systems and technology. Serve as a direct point of cross-functional point of contact for projects involving safety systems and technology. Ensure that all applicable documentation is complete and in accordance with corporate policy and guidelines. Utilize core operational understanding to identify and implement system/process/analysis improvements; perform metrics analysis to identify problems and/or performance trends.

Key Accountabilities:

Technology Support

• Conduct and drive 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
• Drive and support the planning and delivery of the handover of the safety database from client to Parexel were contracted to take over the pharmacovigilance tasks for complex client projects
• Drive and support the planning and delivery of the handover of safety data from Parexel to client at the end of study/project as contracted for complex client projects
• Provide the authorship and reviewer roles for standard operating procedures and controlled documents that pertain to safety technology
• Design and deliver complex integration solutions between Parexel safety technologies and other applications to drive operational excellence, enhanced service capabilities

Organizational Representation

• Represent Safety Technology Management and the safety operations organization and be directly responsible for actions when interfacing 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 and the safety operations organization and be directly responsible for actions when interfacing external auditors and inspectors during the examination of safety technology
• Develop and deliver presentations for the service delivery of Parexel safety technology solutions

Issue Management

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

Team Support

• Train and coach new or developing staff in the systems and activities necessary for the fulfillment of their job responsibilities
• Provide work direction to team members in the execution of their duties for daily operational support and strategic implementation services

Change Management

• Lead and drive change management in accordance with the Software Development Life Cycle through the ownership of activities including impact assessments, testing methodologies, and qualification.
• Lead and drive software updates, change requests and application support for the supported applications
• Lead, design and drive 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
• Collaborate with Global Pharmacovigilance Intelligence Office to ensure Parexel safety systems maintain regulatory compliance and proactively meet requirement as they change

Skills:

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

Knowledge and Experience:

• Safety Supportive Applications (Argus, Vault Safety, EDC, Safety ERP) - 5+ years of experience in all functional areas of chosen safety technology including all secondary tools and processes
• Safety Business Processes - 5+ years of experience working closely with operational teams to manage issues, gather and document requirements, and deliver solutions
• Peer oversight, coaching, training - 1+ years of direct mentorship or training
• Propose and Deliver System/Process Improvements - Demonstratable lead participation in improvement initiatives
• System Validation Activities - 1+ years in design, execution, maintenance activities and their documentation
• Communication Skills - Strong, Fluent in English; demonstrated ability to write technical documentation and deliver clear presentations to stakeholders and clients
• Leadership Representation - 1+ years as a point of contact and directly responsible individual working with cross-functional teams as a safety technology representative

Education:

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