Now Hiring: Pharmaco-Device Vigilance Officer
Location: Galway City
Are you passionate about patient safety, clinical research, and regulatory compliance?
An exciting opportunity has arisen for a Pharmaco-Device Vigilance Officer to join a leading organization supporting clinical trials and medical device investigations across multiple therapeutic areas.
In this role, you'll play a vital part in ensuring that all clinical studies are conducted safely, ethically, and in full compliance with international and EU regulations.
About the Role
As the Pharmaco-Device Vigilance Officer, you'll take the lead in developing and maintaining vigilance systems that safeguard patient welfare and ensure regulatory compliance across all phases of clinical trials.
You'll monitor and manage safety reports, evaluate risk, liaise with sponsors and authorities, and provide expert guidance on pharmacovigilance and device vigilance processes.
This is a fantastic opportunity for someone looking to advance their career in clinical safety within the life sciences sector.
Key Responsibilities
1. Establish and manage pharmacovigilance and device vigilance procedures across sponsored clinical trials.
2. Act as the primary contact for safety and vigilance-related matters.
3. Oversee adverse event and device deficiency reporting, ensuring accuracy and timely submission.
4. Conduct risk assessments to identify and mitigate potential safety issues.
5. Support the preparation of safety reports, including DSURs and other periodic updates.
6. Provide training and guidance to study teams on safety reporting requirements.
7. Collaborate with regulatory authorities and external partners to ensure compliance.
8. Prepare for and support audits and inspections as a subject matter expert in vigilance.
Requirements
Essential:
9. Degree in a medical, clinical, scientific, or related field.
10. Experience in pharmacovigilance or device vigilance within clinical research.
11. Strong understanding of Good Clinical Practice (ICH GCP) and ISO .
12. Excellent organizational and analytical skills.
13. Strong communication and interpersonal skills, with the ability to work independently and as part of a team.
Desirable:
14. Experience within a sponsor or CRO environment.
15. Knowledge of EudraVigilance / EUDAMED systems and MedDRA coding.
16. Familiarity with safety data management and clinical trial systems.
17. Postgraduate qualification in Clinical Research or Life Sciences
What's on Offer
18. Work within a dynamic life sciences organization driving excellence in clinical research.
19. Opportunity to shape safety processes that make a real difference in patient outcomes.
20. Collaborative and supportive team environment.
21. Competitive salary and benefits package.
For more information, please contact
#LI-EB6