The post holder provides cross enterprise technical support within PV Excellence (PVE) and the business, as required.. The post holder supports Global Process Owners(GPOs), Safety Process Leads (SPLs) and the business, by undertaking identified operational tasks.
Key Responsibilities/Activities (dependent On Areas Supported By Each TA)
- Assist GPOs/SPLs to provide strategic oversight for enterprise PV processes.
- Assist GPOs/SPLs to deliver innovative, efficient, holistic, end-to-end safety processes that are compliant with global PV regulations and reflect enterprise business needs, including Process Simplification.
- Provide operational, technical and maintenance support of appropriate PVE Workstreams
- Undertake Template Manager Role to support for PV documentation in VeeVa Vault (Regulatory and Clinical)
- Support interaction between PVE and 3rd Party Vendor Activities for Aggregate Report management
- Provide support for metric collection, compilation and reporting
- Provide support for Management Monitoring
- Manage daily triage of group mailboxes
- Contribute to process improvement
- Undertake role of Subject Matter Expert, when required.
- Business owner of document management systems
- Review content on PVE owned webpages and ensure materials are up to date and fully operational
- Support Signal detection, including CVW
- Support Eudravigilance activities
- Support RMP and Targeted Safety Study (TSS)/Post Approval Safety Study (PASS) activities
- Support eTMF
- Support Medical Devices
- Support Case Awareness Tool/Autolistedness profile/TOI/MedDRA
- Support Medication Error activities
- Support PIER Report generation/meta data change requests
- Support PRION alerts and QRG maintenance
- Provide oversight of local Reference Safety Information updates and address queries
- Provide support for training, inspections, and audits
- Excellent computer skills including Word, Excel, Internet/Intranet, document management systems
- Excellent organisational skills
- 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
- Awareness of PV processes and global PV regulations
- Preferred knowledge of process improvement techniques and ability to analyze performance metrics to drive continuous improvement
- Preferred knowledge of other related disciplines e.g. clinical, regulatory affairs, clinical statistics relevant to aggregate report writing and clinical development
- Demonstrates ability to be able to work independently, in a flexible manner and adjust to change
- Minimum high school diploma or equivalent plus 3-4 years’ experience providing technical support for a high volume medically oriented or Clinical R&D department in a large corporation. Higher education advantageous.
- Familiarity with medical/scientific terminology desirable.
- Working knowledge of R&D organization preferred.
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