Job Purpose
- Provides cross enterprise technical support within PV Excellence (PVE) and the business, as required.
? Supports Global Process Owners (GPOs), Safety Process Leads (SPLs) and the business, by undertaking identified operational tasks.
? Assist GPOs/SPLs to provide support for Pharmacovigilance (PV) processes.
? Provide operational, technical and maintenance support of appropriate PV excellence (PVE) Workstreams.
PV Excellence
? Undertake Template Manager Role to support PV documentation in Veeva Vault (Regulatory and Clinical)
? Provide support for metric collection, compilation, and reporting.
? Provide support for Management Monitoring
? Manage and daily triage of group mailboxes.
? Review content on PVE owned webpages and ensure materials are up to date and fully operational.
? Provide technical support for department processes and maintain documentation/repositories as needed.
? Support eTMF process.
? Support Medical Devices
? Support Case Awareness Tool/Autolistedness profile/TOI/MedDRA/TFQs ? Support for Development Core Safety Information management.
? Support Safety Communications process.
Expected competencies for this role:
? Demonstrates ability to work with tight deadlines under pressure, while maintaining a high level of accuracy, attention to detail and integrity
? Functions as a team player
? Demonstrates ability to effectively communicate (written and verbal)
? Ability to effectively handle and appropriately escalate issues based on risk in a timely manner.
Education Requirements (minimum expected)
A bachelor's degree in health sciences or related disciplines
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