Patient Safety Specialist Role

3 days ago


London, Greater London, United Kingdom ZipRecruiter Full time

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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