Pharmaco-device Vigilance Officer – Fixed Term Contract
About Your New Employer:
- Join a leading clinical trials institute renowned for its innovative research and commitment to advancing healthcare.
- Work within a dynamic, multi-disciplinary team dedicated to ensuring the highest standards of clinical trial safety and compliance.
- Be part of an organization that values professional development and offers opportunities for growth and advancement.
About Your New Job as the Pharmaco-device Vigilance Officer
- Establish and maintain Device Vigilance and Pharmacovigilance processes: As the Pharmaco-device Vigilance Officer, you will support clinical trial activities by ensuring robust safety oversight processes across all study phases.
- Primary point of contact for vigilance-related queries: You will manage the evaluation of vigilance data, implement risk management strategies, and ensure compliance with regulatory requirements.
- Support study teams: Ensure adverse events and device deficiency reports are processed accurately and timely, safeguarding patient and healthcare professional interests.
What Skills You Need for Pharmaco-device Vigilance Officer
Essential Criteria:
- Degree in a medical, clinical, scientific, or related field.
- Prior vigilance experience in clinical studies and knowledge of Good Clinical Practice (ICH GCP and ISO14155).
- Experience in developing vigilance strategies and safety data management.
- Strong project management, organizational skills, and proficiency in basic software packages (e.g., MS Office).
- Excellent written and verbal communication skills in English.
Desirable Criteria:
- Experience in a vigilance role within a commercial or academic setting.
- Experience with Quality Management systems, risk management processes, and clinical research data management.
- Qualification in Pharmacovigilance or related discipline.
- Understanding of MedDRA, device vigilance coding, and EudraVigilance/EUDAMED reporting processes.
- Good Clinical Practice training and experience with trial management software packages.
What’s on Offer for Pharmaco-device Vigilance Officer
- Competitive salary and benefits package.
- Opportunities for professional development and career progression.
- A collaborative and supportive work environment within a leading clinical trials institute.
What’s Next
Apply now by clicking the “Apply Now" button or call Karolina at 091749267 . If the job isn’t quite right but you are looking for something similar, please get in touch.
