Safety Technology Analyst
Hyderabad, India Job ID R0000024058 Category Medical SciencesAbout this Role
Key Accountabilities:
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 in Oracle Analytics
Operational reports configuration and generation in Oracle Analytics
Configure datasets using joins in Oracle Analytics
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
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 systems
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.
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:
2+ years of experience in all functional areas of chosen safety technology including all secondary tools and processes.
2+ years of experience working closely with operational teams to manage issues, gather and document requirements, and deliver solutions.
Experience of supporting team members.
Demonstratable participation in improvement initiatives.
Experience of computerized system methodologies and process.
Fluent in English; demonstrated ability to write technical documentation and deliver clear presentations to stakeholders.
Demonstratable experience working with cross-functional teams as a safety technology representative
Education:
BA/BSc Engineering/Computer Science, Masters or equivalent preferred
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