Vigilance Assessor – Pharmacovigilance Specialist

About the role

Our client in Dublin is seeking a Vigilance Assessor to support post‑marketing evaluation and regulation of medicinal products across Ireland and the EU. The role involves monitoring safety data, detecting signals, and contributing to risk‑minimisation strategies to ensure medicines are used safely.

Key responsibilities

• Conduct signal detection using databases and integrate quantitative and qualitative approaches in line with EU guidance.
• Evaluate signals and adverse events from literature, epidemiological studies and other data sources.
• Provide technical support for safety monitoring, including assessment of Pharmacovigilance Plans, Risk Minimisation Plans and Periodic Safety Update Reports.
• Interpret data from post‑authorisation studies and clinical trials.
• Communicate risk initiatives and scientific information to stakeholders, regulatory authorities and healthcare professionals.
• Liaise with cross‑functional teams, applicants and the broader community on safety matters.

Required profile

• Primary degree in pharmacy or a closely related scientific discipline (e.g., clinical pharmacology).
• Minimum of 2 years of relevant experience in pharmacovigilance or risk management.
• Post‑graduate qualification or ongoing studies in pharmacoepidemiology, medical statistics or a related field.
• Demonstrated knowledge of clinical pharmacology and use of medicinal products in a clinical setting.
• Track record of academic or industry publications in medicine‑related topics.

Required skills

• Excellent data analysis capabilities, including the use of statistical packages.