Senior Safety Technology Analyst

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.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 SupportConduct and drive set-up and support activities associated with the Parexel safety database (and associated systems) including but not limited to:New study set-upPeriodic report configuration and generationAd-hoc report configuration and generationExpedited report rule configurationEnd-user supportDrive 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 projectsDrive 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 projectsProvide the authorship and reviewer roles for standard operating procedures and controlled documents that pertain to safety technologyDesign and deliver complex integration solutions between Parexel safety technologies and other applications to drive operational excellence, enhanced service capabilitiesOrganizational RepresentationRepresent 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 managedRepresent 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 technologyDevelop and deliver presentations for the service delivery of Parexel safety technology solutionsIssue ManagementLead collaboration with Parexel IT, vendor, Parexel Safety Services staff, and clients for the proper analysis, resolution, and closure of issues for supported systemsTeam SupportTrain and coach new or developing staff in the systems and activities necessary for the fulfillment of their job responsibilitiesProvide work direction to team members in the execution of their duties for daily operational support and strategic implementation servicesChange ManagementLead 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 applicationsLead, design and drive the implementation of technology solutions for Safety Services for the purposes of business process optimization and improvementEnsure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standardsCollaborate with Global Pharmacovigilance Intelligence Office to ensure Parexel safety systems maintain regulatory compliance and proactively meet requirement as they changeSkills:Advanced interpersonal, verbal, and written communication skillsClient focused approach to workAdvanced analytical and problem-solving skillsAdvanced organizational and customer service skillsWillingness to work in a matrix environment and to value the importance of teamworkDrive 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 technologiesAdvanced 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 detectionKnowledge of emerging pharmacovigilance safety technology, including AIAdvanced level skills in using standard scripting languages e.g., SQLExperience of industry standard Service Desk ToolsAdvanced level technical writing capabilityAdvanced experience of standard SDLC processes including change managementAdvanced experience of Agile methodologyA flexible attitude with respect to work assignments and new learningDrive and complete multiple and varied tasks with enthusiasm and prioritize workload for others using standard Project Management methodologiesAdvanced experience of system validation and change managementAdvanced knowledge and practical application of computer system regulations and guidance in the pharmaceutical industry including: 21 CFR Part 11, EMA Annex 11, GAMPAdvanced knowledge of Pharmacovigilance roles, standards and practicesAdvanced knowledge of GVP and GCPKnowledge 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 processesSafety Business Processes - 5+ years of experience working closely with operational teams to manage issues, gather and document requirements, and deliver solutionsPeer oversight, coaching, training - 1+ years of direct mentorship or trainingPropose and Deliver System/Process Improvements - Demonstratable lead participation in improvement initiativesSystem Validation Activities - 1+ years in design, execution, maintenance activities and their documentationCommunication Skills - Strong, Fluent in English; demonstrated ability to write technical documentation and deliver clear presentations to stakeholders and clientsLeadership Representation - 1+ years as a point of contact and directly responsible individual working with cross-functional teams as a safety technology representativeEducation:BA/BSc Engineering/Computer Science, Masters or equivalent preferred