Operations

• Develops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed.
• Ensures compliance to Standard Operating Procedures (SOP), Policies and SMP documents
• Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
• Supports annual revenue targets by working with the operational team members and Therapeutic BU Project Managers / Project Directors to ensure accurate and timely recognition of the BU in RBB.
• Provides metrics as appropriate at agreed upon intervals based on assigned tasks.
• Performs other work-related duties as assigned.
• Assist with the management and maintenance of the safety database, including but not limited to:
•  User set-up and maintenance
•  Project-specific configurations
•  Routine safety database patches and updates
•  Routine MedDRA and WHO drug dictionary updates
•  Performance qualification (PQ) scripts for safety database updates/changes
•  Maintenance of systems to ensure compliance with reporting requirements
• Assist with the management and maintenance of other SPVG applications (e.g. SharePoint).
• Provide project support related to safety database issues and data outputs for Safety & PvG projects utilising the Syneos Health safety database.
• Assist with the execution and validation of safety data migrations into the safety database.
• Generate listings, reports and queries from the safety database for internal, client, or regulatory use
• Participate in project meetings as requested.
• Ensure compliance with applicable regulatory requirements, company policies, procedures, and standards.
• Maintain a high level of expertise regarding Safety & PvG systems and applications through participation in internal meetings and professional seminars and workshops
• Assist with other SPVG initiatives as needed.

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