Provide support for the set
- up, maintenance and close out of Global or Regional projects, where delegated by the Global Safety lead of PSS Management team.
- Supports Global Safety lead in the preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, Development Safety Update Report (DSUR) Periodic Safety Reports (PSRs) line listings, and aggregate reports.
- Support Global Safety lead with reconciliation of safety databases, if appropriate.
- Support Global Safety Lead in drafting/modifying and delivering safety presentations as required, to external and internal stakeholders.
- Maintains a comprehensive understanding of Labcorp departmental Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of other procedural documents, e.g.
SOPs, etc.
that impact department.
- Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
- Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
- Support the Global Safety lead in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.
- Build and maintain good departmental relationships across functional units.
- Support the Global Safety lead in preparation of Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision.
- Support the Global Safety lead in preparation of study specific job aids, instructions, trainings and templates.
- Support systems set up during study start up and ongoing maintenance.
- Support the Global Safety lead project specific functional management for assigned projects (access requests, training assignment etc.)
- Assist in TMF management activities as required.
- To support the Global Safety lead in the preparation of internal, client or regulatory audits.
- Support the Global Safety Lead in the provision of data to Safety Committees/DSMBs.
- Demonstrate role-specific competencies on a consistent basis.
- Demonstrate company values on a consistent basis.
- Any other duties as assigned by Global safety lead or PSS management.
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