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 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
Key Skills
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 eg 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
Experience
Bachelor s degree plus 3-4 years experience providing technical support for a high volume medically oriented or Clinical RD department in a large corporation. Higher education advantageous.
Familiarity with medical/scientific terminology desirable. Need demonstrated proficiency and capability in technical aspects of the role in similar environment.
