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.
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