Pharmaco-device Vigilance Officer

10 hours ago

Galway, Ireland Sigmar Recruitment Full time

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. Whats 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. Whats Next Apply now by clicking the Apply Now" button or call Karolina at . If the job isnt quite right but you are looking for something similar, please get in touch.

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