Medical Device Safety Specialist

7 days ago

Stockholm, Stockholm, Sweden Chiesi Farmaceutici S.p.A. Full time
About the Role

We are seeking a highly skilled Medical Device Safety Specialist to join our team at Chiesi Farmaceutici S.p.A. as a Vigilance Lead for Medical Devices and Food Supplements.

Key Responsibilities
  • Design, plan, maintain, and update 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).
  • 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.
  • Contribute to the clinical development of new medical devices and combination products.
  • Support Post-Marketing Surveillance (PMS) program activities, including PMS system documentation, PMS planning, and report management.
  • Review the pertinent sections of the Instruction for Use/packaging materials.
  • 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.
  • Develop and maintain Global SOPs/WIs according to the assigned tasks.
  • Implement training programs in connection with the assigned tasks.
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.
  • Up-to-date knowledge of pre- and post-marketing international vigilance regulations for Medical Devices and Food supplements as well as regulatory safety reporting requirements.
  • Knowledge of the quality aspects of Medical Devices and Food supplements.
  • Good knowledge of Pharmacovigilance at both global and local scale.
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.

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