Deputy QPPV

3 weeks ago


Dublin, Ireland Irish Recruitment Consultants Full time

SRG have partnered with a Dublin-based Medical Devices company, and are pleased to bring this role to market. Hybrid - site in South Dublin (2 days on-site p/w) Salary - €50K + Benefits Start date: ASAP Please be advised this role is available only to Irish, EU, Stamp 4 or Stamp 1G holding citizens currently residing in Ireland. No sponsorship. Duties: - Manage the company EU's Pharmacovigilance (PV) system in compliance with EU Regulation 2019/6 and related guidelines. - Investigate Adverse Events (AEs) associated with company products. - Conduct farm visits for AE information gathering and resolution. - Submit AE reports to the Competent Authorities on time. - Prepare and submit Periodic Safety Update Reports (PSUR) to the UK's Veterinary Medicines Directorate. - Draft annual statements and signal management reports for European authorities. - Coordinate with internal and external stakeholders on PV issues. - Oversee PV agreements and communications with agencies and distributors. - Train company EU staff on PV responsibilities. - Serve as a PV advisor and business partner. - Support R&D and other company expertise areas. - Embrace a proactive, adaptable approach with a readiness to travel. Essential: - Bachelor's degree in a scientific discipline. - 1+ year(s) pharmacovigilance or drug safety experience in pharma or animal health. - Knowledge of pharmaceutical documentation practices. - Animal Health / Veterinary experience. - Proficiency with Microsoft Office applications. - Strong command of written and verbal English Desirable: - 2-3 years in Regulatory Affairs in pharma or animal health. - Veterinary degree preferred. - Trained in EudraVigilance for electronic reporting. Guidant IRC is acting as an Employment Agency in relation to this vacancy. Skills: Pharmacovigilance Regulatory Affairs Adverse Events