Job title: Principal Safety Technology Analyst
Job description: . Lead set-up and support activities associated with the Parexel safety database (and associated systems) including but not limited to: o New study set-up o Periodic report configuration and generation o Ad-hoc report configuration and generation o E
. Lead set-up and support activities associated with the Parexel safety database (and associated systems) including but not limited to: o New study set-up o Periodic report configuration and generation o Ad-hoc report configuration and generation o Expedited report rule configuration o End-user support . Lead 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 . Lead 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 . Proactively look for opportunities to improve as well as provide the authorship and reviewer roles for standard operating procedures and controlled documents that pertain to safety technology . Lead, design and deliver complex integration solutions between Parexel safety technologies and other applications to drive operational excellence, enhanced service capabilities . 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 . Initiate and lead collaboration with Parexel IT, vendor, Parexel Safety Services staff, and clients for the proper analysis, resolution, and closure of issues for supported systems . 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 . Initiate and lead change management in accordance with the Software Development Life Cycle through the ownership of activities including impact assessments, testing methodologies, and qualification. . Initiate and lead software updates, change requests and application support for the supported applications . Initiate, design and lead 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, ERES, and quality standards . Own the relationship and Collaborate with Global Pharmacovigilance Intelligence Office to ensure Parexel safety systems maintain regulatory compliance and proactively meet requirement as they changeQualifications – BSc Computer Science/ Engineering, Masters or equivalent preferred . Exceptional interpersonal, verbal, and written communication skills . Client focused approach to work . Expert analytical and problem-solving skills . Exceptional organizational and customer service skills . Willingness to lead in a matrix environment and to value the importance of teamwork . Lead a team working through problem management. Be accountable for the implementation of the solution(s) . Independently define and take ownership of core tasks related to the support and maintenance of safety technologies . Prior expert level experience in System Administration and application support skills within pharmacovigilance safety technology, including complex configurations and client-specific solutions across safety databases, gateway / E2B, report development, signal detection. . Experience 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 . Expert level technical writing capability . Advanced experience of standard SDLC processes including change management . Advanced experience of Agile methodology . Proactive identification of new work and new learnings . Lead multiple and varied tasks with enthusiasm and prioritize workload for others using standard Project Management methodologies . Advanced experience of system validation and change management . Expert 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
Location: Hyderabad, Telangana
Job date: Sat, 19 Feb 2022 23:07:40 GMT
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