Senior Medical Device Safety Specialist

3 settimane fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
Who we are looking for Purpose


• To establish, uphold, and assess the efficacy of the vigilance system for medical devices and food supplements, ensuring adherence to Health Authorities and Standards.

• Advocate for the secure utilization of medical devices and food supplements throughout the organization while providing specialized guidance.

• To create, sustain, and evaluate the effectiveness of the Product Quality Complaint system, in alignment with Health Authorities and Standards.

• To serve as a cross-functional expert for initiatives involving vigilance and oversight of medical devices, food supplements, and combination products.

Main Responsibilities


• Design, strategize, maintain, and refresh the activities and processes related to Medical Devices, food supplements, and Product Quality Complaints within the Global Pharmacovigilance Center of Excellence department;

• Engage in cross-functional teams as a subject matter expert for Medical Devices, food supplements, and Product Quality Complaints to ensure coherence on any safety concerns identified during investigations, trend analyses, and risk assessments.

• Deliver expertise in Medical Device, Food supplement, and Product Quality Complaint safety, sharing medical, scientific, and regulatory insights with relevant stakeholders (both internal and external);

• Provide a Global Pharmacovigilance perspective regarding the criteria and procedures for exchanging technical safety data between manufacturing teams and Global Pharmacovigilance;

• Oversee the pertinent documentation and coordinate activities with Contract Research Organizations (CROs) or other service providers to guarantee data integrity for regulatory submissions;

• Monitor, evaluate, and apply trending methodologies to the vigilance data submitted to Health Authorities;

• Conduct aggregate reviews of adverse events for trend detection related to Medical Devices and Food supplements;

• Contribute to the design, planning, and execution of analyses of safety data beneficial for assessing the safety and performance of medical devices;

• Assist in the clinical development of new medical devices and combination products;

• Support the management of combination products in the post-marketing phase;

• Facilitate Post-Marketing Surveillance (PMS) program activities, including PMS system documentation, PMS planning, and report management;

• Ensure the accuracy of Medical Devices and Food supplement analysis, interpretation of results, and content distribution to Post-Marketing Surveillance and Vigilance activities;

• Review relevant sections of the Instruction for Use/packaging materials;

• Keep abreast of literature concerning the safety of medical devices and food supplements;

• Ensure the implementation of innovative processes and tools for Medical Devices, Food supplements, and Product Quality Complaints to meet established compliance standards;

• Guarantee 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;

• Assess Product Quality Complaints (PQCs) regarding potential patient safety impact and conduct necessary evaluations;

• Maintain and update the PQC system in collaboration with GMD QA and other stakeholders;

• Develop and sustain Global Standard Operating Procedures (SOPs) and Work Instructions (WIs) according to assigned tasks;

• Implement training programs related to assigned responsibilities;

• Initiate deviations linked to the activities under this role and participate in investigations and CAPA Plan implementation;

• Engage in audit and inspection activities;

Experience Required

A minimum of 5-7 years of experience in international Pharmacovigilance or with medical devices, including at least 3-5 years of experience in medical device safety.

Education

A Master’s degree in health-related fields, PhD or similar preferred.

Languages

Fluent in English.

Technical Skills


• Current knowledge of pre- and post-marketing international vigilance regulations for Medical Devices and Food supplements, as well as regulatory safety reporting requirements.

• Understanding of the quality aspects of Medical Devices and Food supplements.

• Comprehensive knowledge of the regulatory and scientific environment to monitor Medical Devices and Food supplements safety issues and ensure compliance.

• Strong understanding of Pharmacovigilance at both global and local levels.

• Familiarity with the MedDRA coding dictionary and its principles, along with IMDRF coding.

Soft Skills
  • Excellent communication skills
  • Strong planning and organizational abilities
  • Effective problem-solving skills
  • Strategic thinking capabilities
  • Team collaboration skills

What we offer

You would be part of a dynamic, rapidly growing, challenging, and supportive environment. At Chiesi, we firmly believe that our people are our most valuable asset, which is why we invest in continuous training, learning, and development. We strive to promote and meet development needs, placing particular emphasis on the quality of our working environment and collective well-being.
We want our employees to come to work happy every day, and we recognize the importance of achieving the right work-life balance to perform at their best. Therefore, we offer a flexible working approach, remote working options, assistance in the relocation process, tax support services for international colleagues, and many other employee-focused services.

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