Patient Safety Specialist
- 12 months
- £26 per hour
- White City / Hybrid - Office based 3 days a week
Tate have teamed up with one of the largest Pharmaceutical companies to recruit for a Patient Safety Specialist for 12 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. Knowledge of national and international regulations is vital in this role.
Role responsibilities:
- 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 externalised, liaise with the respective External Service Providers to ensure 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 Organisation 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 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
Experience required:
- 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
Please be aware this advert will remain open until the vacancy has been filled. Interviews will take place throughout this period, therefore we encourage you to apply early to avoid disappointment.
Tate is acting as an Employment Business in relation to this vacancy.
Tate is committed to promoting equal opportunities. To ensure that every candidate has the best experience with us, we encourage you to let us know if there are any adjustments we can make during the application or interview process. Your comfort and accessibility are our priority, and we are here to support you every step of the way. Additionally, we value and respect your individuality, and we invite you to share your preferred pronouns in your application.