On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for a Senior Human Factor Engineer who can join an exciting working environment in a dynamic atmosphere. Role Description: The Candidate will be responsible for designing new products by defining user requirements and translating them into solution to optimize the user experience with products that improves patient lives. The candidate will be responsible for defining the Human factors strategy to support the human factors engineering files and to achieve designing products that increase loyalties and satisfaction of the final users (customers/patients/HCPs). The Human factors process will have to be developed accordingly to regulations and ISO standards requirements ( ISO14971, IEC 62366, FDA HFE guidelines).



The candidate will be responsible for managing external partners that will be responsible for carrying out the Human Factors studies also supporting the design of the testing based on a risk-based approach. The candidate will be leading the preparation of task analysis, formative and summative study documentation, known use errors documentation, usability risk assessment, HF plan and final reports. All the Human Factors file index will be under the candidate responsibility and accountability. The candidate will be responsible for preparing the Human Factors submission file, ensuring alignment with regulatory expectations and compliance with FDA, EMA, and other applicable authority guidelines. The candidate will participate in the review process with regulators. The candidate will be responsible of integrating the HF stream and correspondening documentation into the design development management (from feasibility to life cycle management). Therefore, the candidate should be knowledgeable of design control principle and

📌 Senior human factor engineer (Roma)
🏢 IQVIA Italia
📍 Roma