Pharmacovigilance & Regulatory Lead, Ireland

Biopharma Careers in Dublin, Ireland, is seeking a Safety and Regulatory Affairs Officer to act as Pharmacovigilance Responsible Person for our Irish affiliate and lead regulatory projects to keep medicines safe and compliant. You will manage safety reporting, oversee PV vendors and systems, draft SDEAs, and drive regulatory submissions, variations and PSURs.

Collaboration with HPRA, HSE and IPHA is central, supported by a global team and a focus on high-quality labelling and lifecycle