Medical Device, Combinations
1 mese fa
• To set up, maintain and evaluate the performance of the medical device vigilance and food supplement system, in compliance with the requirements of Health Authorities and Standards
• Promote the safe use of medical devices and food supplements across the organisation and provide expert advice
• To set up, maintain and evaluate the performance of the Product Quality Complaint system, in compliance with the requirements of Health Authorities and Standards
• To be a cross-functional reference person for projects involving vigilance and surveillance aspects of company medical devices, food supplements and combination products.
• Designing, planning, maintaining and updating the Medical Device, food supplement and Product Quality Complaint activities and processes within the Global PV Center of Excellence department;
• Participate in cross-functional teams as a reference person for Medical Devices, food supplements and Product Quality Complaints to ensure alignment on any safety issues identified during investigations, trend analyses and risk assessments.
• Provide Medical Device, Food supplement and Product Quality Complaint safety expertise and share medical, scientific and regulatory information with concerned stakeholders (internal and external);
• Provide a Global PV perspective regarding the criteria and pathway for exchanging technical safety data between manufacturing teams and Global Pharmacovigilance;
• Manage the relevant documentation and coordinate activities with Contract Research Organizations (CROs) or other service providers to ensure data quality for regulatory submission;
• Monitor, analyze and apply trending methodologies to the vigilance data submitted to Health Authorities;
• Perform aggregate review of adverse events for trend detection of Medical Devices and Food supplements;
• Provide input for designing, planning and conducting analyses of safety data useful for the assessment of medical device’s safety and performance;
• Contribute to the clinical development of new medical devices and combination products
• Contribute to the management of combination products in the post-marketing setting;
• Support Post-Marketing Surveillance (PMS) program activities, including PMS system documentation, PMS planning and report management;
• Produce and ensure the accuracy of Medical Devices and Food supplement analysis, interpretation of results and content distribution to Post-Marketing Surveillance and Vigilance activities;
• Review the pertinent sections of the Instruction for Use/packaging materials
• Monitor literature concerning the safety of medical devices and food supplements;
• Ensure implementation of innovative Medical Devices, Food supplement and Product Quality Complaint processes and tools to meet the established compliance standards;
• Ensure compliance with vigilance and surveillance requirements detailing case management responsibilities and timelines as defined in new/ updated Agreements for medical devices manufactured by Chiesi;
• Contribute to due diligence for the acquisition of new Medical Devices and Food supplements;
• Evaluate Product Quality Complaints (PQCs) concerning potential patient safety impact and perform the necessary evaluations
• Maintaining and updating the PQC system in collaboration with GMD QA and other stakeholders
• Develop and maintain Global SOPs/ WIs according to the assigned tasks;
• Implement training programs in connection with the assigned tasks;
• Open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation;
• Participate in audit and inspection activities;
Minimum 5-7 years of experience in international Pharmacovigilance or with medical device with at least 3-5 years of experience in medical device safety
EducationMaster degree in health-related fields, PhD or similar preferred
LanguagesEnglish fluent
Technical Skills • Up-to-date knowledge of pre- and post-marketing international vigilance regulations for Medical Devices and Food supplement well as regulatory safety reporting requirements
• Knowledge of the quality aspects of Medical Devices and Food supplement;
• Full understanding of regulatory and scientific environment to monitor Medical Devices and Food supplement safety issues and ensure compliance
• Good knowledge of Pharmacovigilance at both global and local scale
• Knowledge of MedDRA coding dictionary and its principles and IMDRF coding
- Communication skills
- Planning and organizational skills
- Problem solving
- Strategic thinking
- Team working
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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