Medical Device, Combinations Specialist

4 settimane fa

Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pieno

Job Summary

We are seeking a highly skilled Medical Device, Combinations Specialist to join our Global Pharmacovigilance team at Chiesi Farmaceutici. As a key member of our team, you will be responsible for setting up, maintaining, and evaluating the performance of the medical device vigilance and food supplement system, ensuring compliance with Health Authorities and Standards.

Main Responsibilities

  • 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.
  • Participating 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.
  • Providing Medical Device, Food supplement, and Product Quality Complaint safety expertise and sharing medical, scientific, and regulatory information with concerned stakeholders (internal and external).
  • Managing the relevant documentation and coordinating activities with Contract Research Organizations (CROs) or other service providers to ensure data quality for regulatory submission.
  • Monitoring, analyzing, and applying trending methodologies to the vigilance data submitted to Health Authorities.
  • Performing aggregate review of adverse events for trend detection of Medical Devices and Food supplements.
  • Providing input for designing, planning, and conducting analyses of safety data useful for the assessment of medical device's safety and performance.
  • Contributing to the clinical development of new medical devices and combination products.
  • Contributing to the management of combination products in the post-marketing setting.
  • Supporting Post-Marketing Surveillance (PMS) program activities, including PMS system documentation, PMS planning, and report management.
  • Producing and ensuring the accuracy of Medical Devices and Food supplement analysis, interpretation of results, and content distribution to Post-Marketing Surveillance and Vigilance activities.
  • Reviewing the pertinent sections of the Instruction for Use/packaging materials.
  • Monitoring literature concerning the safety of medical devices and food supplements.
  • Ensuring implementation of innovative Medical Devices, Food supplement, and Product Quality Complaint processes and tools to meet the established compliance standards.
  • Ensuring compliance with vigilance and surveillance requirements detailing case management responsibilities and timelines as defined in new/updated Agreements for medical devices manufactured by Chiesi.
  • Contributing to due diligence for the acquisition of new Medical Devices and Food supplements.
  • Evaluating Product Quality Complaints (PQCs) concerning potential patient safety impact and performing the necessary evaluations.
  • Maintaining and updating the PQC system in collaboration with GMD QA and other stakeholders.
  • Developing and maintaining Global SOPs/WIs according to the assigned tasks.
  • Implementing training programs in connection with the assigned tasks.
  • Opening deviations related to the activities under the role and contributing to the investigation(s) and CAPA Plan implementation.
  • Participating 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.
  • English fluent.

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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