Safety Technology Specialist

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 with oracle Analytics.

• Ad-hoc report configuration and generation with oracle Analytics.

• Expedited report rule configuration with oracle Analytics.

• 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 contracted. Adhere 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:

Bachelor’s degree in engineering/computer science, master's or equivalent preferred.