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Patient Safety Specialist
3 weeks ago
Patient Safety Specialist
London-Hybrid on site 3 days
Contract Length: 12 months Maternity cover
Job Purpose:
To support management of Patient Safety operational processes at the country organization, ensuring compliance with global and local procedures, national and international regulations, standards, and guidelines for vigilance of both marketed and investigational products (incl. drugs, food supplements and medical devices).
Major Accountabilities:
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. When case processing activities are externalized, liaise with the respective External Service Providers to ensure Procedures' compliance.
Manage reporting/submission/distribution of safety reports/updates/information (, 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.
Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements
Perform reconciliation with other departments (, 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 Organization 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
Other agreed tasks assigned by manager
Key Performance Indicators:
Quality and timely reporting of KPI and safety reports/updates
No critical findings in audits or inspections
Internal and external customer satisfaction
Education & Qualifications:
Health Care Sciences Professional (, Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience
Experience:
• Previous experience with documentation would be advantageous.
Skills & Knowledge:
• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology
• Good communication and interpersonal skills
• Quality and results oriented.
• Computer skills
