Pharmaceutical Safety Specialist

7 days ago

London, Greater London, United Kingdom ZipRecruiter Full time

Are you looking for a challenging role in patient safety?

ZipRecruiter is seeking an experienced Pharmaceutical Safety Specialist to join our team in London.

Salary: £28-33 per hour umbrella rate

Job Description:

We are responsible for the management of Patient Safety operational processes, ensuring compliance with global and local procedures, and international regulations, standards, and guidelines for vigilance of both marketed and investigational products.

  1. 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.
  2. Transcription, translation, and data entry into safety systems accurately and consistently with focus on quality and timeliness.
  3. Reporting, submission, and 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 Organization Departments.
Key Responsibilities:
  1. Development, update, and implementation of local procedures to ensure compliance with Patient Safety global procedures and requirements.
  2. 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.
  3. Management and maintenance of all relevant local Patient Safety databases.
  4. Screening of relevant local literature articles as appropriate.
  5. Preparation and submission of 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.
  6. Development and update of training materials for vigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, as applicable.
  7. Support to internal audits, LHA inspections and implementation of the respective CAPA plan.
Requirements:
  • Previous experience within patient safety and documentation would be beneficial.
  • Knowledge of pharmacological and medical terminology.
  • Quality and results-oriented individual.
  • Computer skills.
What's Offered:
  • 12-month contract with potential for extension.
  • Hybrid work model (3 days per week in London office).
  • Opportunity to work with a leading global pharmaceutical company dedicated to improving patients' futures.

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