Pharmacovigilance Lead

About the role

Eirgen Pharma is seeking a Pharmacovigilance Lead to establish, implement, maintain and continuously improve its Pharmacovigilance (PV) system. The role ensures compliance with EU, HPRA, FDA and other international regulations while safeguarding patient safety throughout the product lifecycle.

Key responsibilities

• Establish, implement and maintain the company's PV system in line with EU, HPRA, FDA and other regulatory requirements.
• Manage the Pharmacovigilance Quality Management System to ensure inspection readiness and continuous compliance.
• Develop and maintain PV procedures, quality documentation, the Pharmacovigilance System Master File (PSMF) and key performance metrics.
• Collect, assess, process and submit adverse event reports within required timelines.
• Conduct signal detection, benefit‑risk assessments and risk‑management activities, including maintaining Risk Management Plans.
• Prepare and submit aggregate safety reports (PSURs/PBRERs, DSURs) and support regulatory safety responses.
• Perform medical literature surveillance and ensure appropriate processing of reportable safety information.
• Monitor evolving PV legislation and implement regulatory changes.
• Collaborate with Regulatory Affairs on marketing authorisations, product lifecycle activities and regulatory submissions.
• Establish and manage Pharmacovigilance Agreements and oversee external vendors.
• Support audits, inspections, CAPAs and quality risk‑management activities.
• Provide PV expertise, training and guidance across the organisation.
• Drive continuous improvement initiatives for PV systems, processes and performance.

Required profile

• Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences or a related scientific discipline.

Required skills

• Pharmacovigilance System Master File (PSMF) management
• Signal detection
• Benefit‑risk assessment
• Risk‑management plan development
• Preparation of PSUR/PBRER/DSUR reports
• Medical literature surveillance