Safety Technology Specialist
2 months ago
When our values align, there's no limit to what we can achieve.
Key Accountabilities :
Technology Support
Under supervision, 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 in 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 in the planning and delivery of the handover of safety data from Parexel to client at the end of study/project as contractedAdhere to standard operating procedures and controlled documents that pertain to safety technology.
Organizational Representation
Interface 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.
Support colleagues when working with external auditors and inspectors during the examination of safety technology
Issue Management
Under supervision, collaborate with Parexel IT, vendor, Parexel Safety Services staff, and clients for the proper analysis, resolution, and closure of issues for supported systems.
Team Support
Provide support to new staff in the systems and activities necessary for the fulfillment of their job responsibilities.
Change Management
Under supervision, support change management in accordance with the Software Development Life Cycle.
Under supervision, support execution of tasks for software updates, change requests and application support for the supported applications.
Under supervision, 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 to a team working through problem management
Under supervision, take ownership of core tasks related to the support and maintenance of safety technologies
Basic System Administration and application support skills within pharmacovigilance safety technology, including at least one of: safety databases, gateway / E2B, report development, signal detection.
Basic skills in using standard scripting languages e.g., SQL
Knowledge of industry standard Service Desk Tools
Basic technical writing capability
Knowledge of standard SDLC processes including change management
Knowledge of Agile methodology
A flexible attitude with respect to work assignments and new learning
Under supervision, complete multiple and varied tasks with enthusiasm and prioritize workload
Knowledge of system validation and change management
Basic knowledge of computer system regulations and guidance in the pharmaceutical industry including: 21 CFR Part 11, EMA Annex 11, GAMP
Basic knowledge of Pharmacovigilance roles, standards and practices
Basic knowledge of GVP and GCP
Education:
BA/BSc Engineering/Computer Science, master's or equivalent preferred.
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