Medical Safety Officer - Roper, United States - Stellar Ventures

Stellar Ventures
Stellar Ventures
Verified Company
Roper, United States

1 month ago

Michael Johnson

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Michael Johnson

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Description

ID#: 1690

Your Mission

  • Act as Medical Safety Representative for the review and/or approval of CER, PMCF, regular safety reports (including PMS, PSUR, SSCP) and risk management documents
  • Provide medical expertise in the evaluation of patient/user safety risks through the development, support, review, and approval of safety assessments, case risk assessments, health risk assessments, and safety signals, as well as for cross-functional teams, safety committees, task forces, workflows, and business partners, and represent the positions, processes, and guidelines of Medical & Scientific Affairs
  • Ensure appropriate metrics for evaluating patient safety processes, represent views on product safety, and lead in a matrix environment through scientific expertise and organizational influence
  • Support the Complaints & Vigilance department in handling complaints and post-market regulatory reporting, particularly in regards to assessing harm for a specific event
  • Make continuous contributions to the product's list of harms and hazards, reviewing and ensuring consistency in the severity of harms throughout the pre- and post-market risk management process
  • Contribute to departmental and cross-functional improvement initiatives within your scope of responsibilities
  • Promote safety awareness and a patient-centered mindset throughout the global Karl Storz organization
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