Medical Device Safety Specialist
2 mesi fa
We are seeking a highly skilled Medical Device Safety Specialist to join our team at Chiesi Group. As a key member of our Pharmacovigilance team, you will be responsible for ensuring the safe use of medical devices and food supplements across the organization.
Main Responsibilities- Design, plan, maintain, and update medical device and food supplement 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).
- Manage 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 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 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 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 necessary evaluations.
- Maintain and update the PQC system in collaboration with GMD QA and other stakeholders.
- Develop and maintain Global SOPs/WIs according to assigned tasks.
- Implement training programs in connection with assigned tasks.
- Open deviations related to activities under the role and contribute to 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.
- Master degree in health-related fields, PhD or similar preferred.
- English fluent.
- 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.
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