Pharmacovigilance Associate
Our client, a leading global pharmaceutical organization, is seeking a Pharmacovigilance Associate to join their Citywest office in Dublin.
This is a role responsible for leading the coordination and implementation of all pharmacovigilance (PV) activities to ensure the organization's legal and ethical obligations are met.
As the primary point of contact for pharmacovigilance matters within the affiliate, you will liaise with the National Regulatory Agency and the company’s Pharmacovigilance and Patient Safety (PPS) function. You will provide strategic leadership, manage PV operations, and guide a dedicated team to deliver excellence in patient safety.
This position reports directly to the Affiliate Medical Director, with an indirect reporting line to the EU Qualified Person for Pharmacovigilance (QPPV) on PV-related matters.
Key Responsibilities
* Build strong business relationships across the affiliate to embed patient safety standards.
* Drive continuous improvement of PV systems in collaboration with PPS experts.
* Oversee recruitment, training, coaching, and performance management of PV staff.
* Monitor PV compliance, workload, and resources; address any compliance issues proactively.
* Ensure PV processes cover safety data from digital media and internet sources.
* Manage local Safety Data Exchange Agreements (SDEAs) in line with company procedures and local regulations; maintain the PPS PV Agreements Database.
* Serve as the primary contact for PV audits and regulatory inspections; ensure timely responses and corrective action implementation.
* Support vendor audits and oversee corrective action plans.
* Collaborate with the Affiliate Risk Management Team to review Risk Management Plans (RMPs) and implement minimisation measures.
* Monitor the safety profile of medicinal products and escalate emerging concerns appropriately.
* Communicate significant safety data changes to the PPS Product Safety Team Lead and EU QPPV.
* Develop robust after-hours reporting and disaster recovery plans for critical PV processes.
* Promote cross-functional understanding of PV requirements within the affiliate.
Qualifications & Experience
* Degree in medicine, pharmacy, life sciences, or a related field (or equivalent).
* 2–5 years’ experience in a pharmacovigilance role within the pharmaceutical industry; people management experience preferred.
* Strong written, verbal, and presentation skills.
* Fluency in English (written and spoken) and the local language.
* Proven ability to work cross-functionally and build effective relationships.
* High commitment to regulatory compliance and patient safety.
* Customer-focused mindset with a proactive, solutions-oriented approach.
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