Safety Specialist

3 weeks ago

London Area, United Kingdom PE Global Full time

PE Global are currently recruiting for Patient Safety Specialist for a contract role with a leading multinational Pharma client based in London - Hybrid.

Job Responsibilities

Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis 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 Novartis Procedures’ compliance.


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 Organization Departments.


Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national 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 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.


Requirements

Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.


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



Interested candidates should submit an updated CV.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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