About the job

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 HPRA (Health Products Regulatory Authority) 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 EudraVigilance 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.

• Life sciences, pharmacy, nursing, or related healthcare degree.
• Demonstrable experience in a pharmacovigilance/drug safety role, ideally within a pharmaceutical company, CRO, or PV service provider operating under HPRA (Health Products Regulatory Authority) oversight.
• Working knowledge of MedDRA coding and case processing in a recognised safety database (e.g. ArisG, ArgusSafety, or similar).
• Solid understanding of EU pharmacovigilance legislation (Directive 2010/84/EU, Regulation (EU) No 1235/2010) and GVP (Good Pharmacovigilance Practice) modules.
• Excellent written and verbal communication skills, with strong attention to detail and accuracy under regulatory timelines.

Desirable Criteria

• Experience supporting signal detection, PSUR/PBRER, or RMP preparation.
• Prior involvement in PV audits or regulatory inspections.
• Experience working within a QPPV/deputy QPPV support structure.
• Postgraduate qualification in pharmacovigilance, pharmacoepidemiology, or a related discipline.
• Experience with vendor/partner oversight for outsourced PV activities.

• Meticulous attention to detail, particularly in case data accuracy and regulatory reporting timelines.
• Strong organisational skills, able to manage competing case processing deadlines.
• Comfortable working within a highly regulated, audit-driven environment.
• Collaborative team player, able to liaise effectively across regulatory, clinical, and quality functions.
• Proactive approach to identifying and escalating potential safety signals or compliance risks.