Medical Device Safety Specialist
4 settimane fa
About Us
Chiesi is a leading international pharmaceutical and healthcare company with a rich history of innovation and commitment to excellence. With over 85 years of experience, we operate in 31 countries and employ over 7,000 talented individuals worldwide.
Our Mission
We strive to improve people's quality of life by acting responsibly towards society and the environment. Our research and development efforts focus on creating innovative drugs in key therapeutic areas, and we are proud to be the largest global pharmaceutical group to be awarded B Corp Certification.
Our Values
We believe that our people are our greatest asset, and we foster a culture of transparency, ethics, and collaboration. Our diverse team is made up of individuals from different backgrounds, cultures, and perspectives, and we celebrate our differences as a strength.
Job Summary
We are seeking a highly skilled Medical Device Safety Specialist to join our Global Pharmacovigilance team. As a key member of our team, you will be responsible for ensuring the safe use of medical devices and food supplements across our organization. Your expertise will be essential in promoting a culture of safety and compliance within our company.
Key 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 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.
Requirements
- 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.
- Fluent in English.
- 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.
What We Offer
We offer a dynamic, fast-growing, challenging, and friendly environment. We invest in continuous training, learning, and development, and we strive to promote and satisfy development needs. We prioritize the quality of our working environment and collective well-being, and we offer flexible working approaches, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services.
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