Patient Safety Graduate
Job Type: 12 Months Fixed Term Contract
Employment Start Date: ASAP
Hours of work: Mon – Fri (35 hours a week)
Onsite requirement: This will be a hybrid role, with 3 days per week on site.
Location: West London, England
Salary: £31,050 per annum holidays, sick pay, pension
Job Purpose:
To support management of Patient Safety operational processes at Country Organization ensuring compliance with global and local procedures, national and international regulations/ standards/ 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 products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs), Literature, Spontaneous Reports, and any other source of information.
- Liaise with the External Service Provider for case processing to ensure compliance with Procedures.
- Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
- Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects/ initiatives that potentially involve safety data collection (POPs, DEAs, SM/SML, etc.) follow the vigilance 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
- 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.
- Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan
- Other agreed tasks assigned by manager, including surveillance and monitoring of national pharmacovigilance regulations and provide update to global Patient Safety organization, and interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
Experience:
- Previous experience with documentation would be advantageous.
- Fluent in both written and spoken English
- Knowledge of national and international regulations for pharmacovigilance would be advantageous
- Knowledge of pharmacological and medical terminology would be advantageous
- Good communication and interpersonal skills
- Quality and results oriented
- Computer skills
You must have graduated from a UK university within the last 2 years to be eligible for this graduate position.