Patient Safety Specialist

PE Global (UK); Greater London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

PE Global (UK) is actively recruiting for a Patient Safety Specialist to join a major pharma client in London on a 12‑month hybrid contract. The role focuses on pharmacovigilance operations, AE management, and regulatory reporting to health authorities, with collaboration across local and global teams.

The candidate should have a health care sciences background or life science degree, strong regulatory and safety knowledge, and be capable of training others and driving process improvements.

Qualifications

• Health care professional degree or life science background.
• Ability to collaborate across functions and boundaries.
• Experience in operations management and execution.
• Experience in employee training.
• Knowledge of safety science.

Responsibilities

• Support management of pharmacovigilance processes to ensure compliance with global/local procedures and regulations.
• Manage collection, processing, documentation, reporting and follow-up of all adverse events from trials and studies.
• Liaise with external service providers to ensure accurate data transcription and timely reporting.
• Record, track and distribute safety documents such as SAEs and SRs with other departments.
• Coordinate safety reporting to Local Health Authorities and clinical operations.
• Monitor global/regional pharmacovigilance regulations and provide updates to the PV organization.
• Develop and update local procedures to align with PVO global procedures and national requirements.

Skills

Healthcare background

Pharmacovigilance

Regulatory compliance

Cross-functional collaboration

Training delivery

Education

Life science degree

Healthcare professional degree

Job description

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.

Job Responsibilities

• 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.

Requirements

• 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***