Patient Safety Specialist Role
3 days ago
Job Description
- Patient Safety Specialist
Tate have teamed up with one of the largest Pharmaceutical companies to recruit for a Patient Safety Specialist for 6 months.
The ideal candidate will come from a pharmaceutical background having experience in managing the collection, processing, documentation, reporting and follow-up of all adverse event reports. Vigilance specialist strong>
- Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs), Literature, Spontaneous Reports, and any other source of information.
- Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness.
- Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organisation Departments.
- Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and requirements
- Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
- Management and maintenance of all relevant local Patient Safety databases
- Ensure that relevant local literature articles are screened as appropriate.
- Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
- Develop and update training materials for vigilance and ensure training of Country Organisation associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, as applicable
- Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan
Estimated salary: £26 per hour
A competitive hourly rate is available for this role.
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