Patient Safety Specialist

PE Global are currently recruiting for Patient Safety Specialist for a 12 month contract role with a leading multinational Pharma client based in London – Hybrid.

• To support management of operational processes in ensuring compliance with our global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of our marketed and investigational products
• Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all our products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
• Liaise with the respective External Service Providers to ensure our Procedures’ compliance with transcribing and entering data of all Adverse Events from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
• Record and track receipts, submissions and distributions of documents like SAEs and SRs, in cooperation with other departments
• Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
• Work with other local/global PV associates to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
• Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.
• Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
• Management and maintenance all relevant assigned PVO databases, if applicable.
• Develop and update training materials for pharmacovigilance
• Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections.

• Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience
• Functional Breadth.
• Collaborating across boundaries.
• Operations Management and Execution.
• Employee Training.
• Safety Science.

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