Safety Officer

Description

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Global Safety. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

The Safety Officer (SO) is responsible for the handling of product safety (e.g., pharmacovigilance, device or cosmetovigilance) issues within the Excelya PV & Safety team. The SO maintains the required level of understanding of regional, national, and international vigilance legislation and is accountable for safety processing, assessment, coding, and reporting activities in compliance with the client's and/or Excelya's SOPs and applicable safety legislation.

The SO follows Excelya and Client policies, procedures, instructions, and guidance, ensuring good documentation practices and data privacy requirements are met, participates in trainings, meetings, audits, and inspections, maintains up-to-date CV and training records, escalates deviations or issues, operates the 24/7 safety phone line, ensures proper delegation of tasks, collects, documents, assesses, and reports case reports, complaints, queries, and requests within agreed timelines, and operates electronic systems for case processing, coding, and reporting to authorities.

Additionally, the SO maintains tracking systems, monitors changes in vigilance legislation, updates quality management system documents, performs filing, reconciliation, and submissions of vigilance-related documents, handles communication with external stakeholders, ensures reference safety information is appropriately communicated, conducts trainings, oversees stakeholder compliance, provides input to safety data exchange agreements, performs translations and literature searches, prepares aggregate safety reports, Risk Management Plans, trend reports, risk-benefit assessments, and the PV System Master File/Safety Management Plan, monitors mailboxes, compliance, and KPIs, assists in promotional activities, RFIs/RFPs, acts as backup for Safety Assistant or other SO responsibilities, and assumes other related responsibilities as assigned by the Line Manager/Safety Manager/Director in accordance with Excelya SOPs.

Education: Health or Life Science Graduate.

Languages: Fluency in Greek and English, both written and spoken, is required. Multilingual abilities, especially in Italian or German, are considered beneficial.

Work Experience: Experience not required but relative experience up to 1 year in pharmacovigilance, regulatory affairs, medical communications and/or clinical research is an asset.

Skills: MS Outlook, Word, Excel, Power Point literate; good organization and communication skills; sense of responsibility and confidentiality; ability in handling documents/trackers; attention to detail; ability to multi-task; team player; self-motivated and able to work both independently and within teams; ability to perform as trainer

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Here's what makes us unique— We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey. Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission