Role Overview

The successful candidate will support the end-to-end pharmacovigilance process, from adverse event case receipt and processing through to signal management and regulatory reporting, ensuring compliance with MHRA (Medicines and Healthcare products Regulatory Agency) requirements and applicable pharmacovigilance legislation. This role suits a life sciences or healthcare professional with strong attention to detail and a solid understanding of drug safety principles.

Key Responsibilities

• Receive, triage, and process adverse event (AE) and adverse drug reaction (ADR) reports from all sources (spontaneous, clinical trial, literature, and solicited).
• Perform case data entry, medical coding (MedDRA), and quality review of individual case safety reports (ICSRs) in the company's safety database.
• Ensure timely submission of expedited and periodic safety reports in line with regulatory timelines.
• Support signal detection and evaluation activities, contributing to periodic safety update reports (PSURs/PBRERs) and risk management plans (RMPs).
• Submit ICSRs and aggregate reports via the MHRA's ICSR submission gateway and, where applicable, the Yellow Card scheme as required.
• Assist with literature surveillance, screening relevant publications for potential safety information.
• Support PV audits and inspections, maintaining audit-ready documentation and case files at all times.
• Liaise with regulatory affairs, clinical operations, medical information, and quality teams on safety-related matters.
• Contribute to the maintenance and continuous improvement of PV standard operating procedures (SOPs).
• Support training of internal stakeholders and partners on pharmacovigilance reporting obligations.