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You serve as Medical Safety representative for the review and/or approval of CER, PMCF, periodic safety reports (incl. PMS, PSUR, SSCP) and risk management file documents
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You provide medical expertise in assessing patient/user safety risks through the development, support, review, and approval of safety evaluations, case risk assessments, health hazard evaluations, and safety signals as well as to cross-functional teams, safety committees, taskforces, work streams, and business partners, representing Medical & Scientific Affairs positions, processes, and guidance
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You ensure appropriate metrics for assessing patient safety processes, represent product safety views, and lead in a matrix environment through scientific expertise and organizational influence
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The support of the Complaints & Vigilance department with post-market complaint and regulatory reporting requirements is also one of you tasks, specifically, as it pertains to the assessment of harm for a particular event
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You continuously contribute to and review the product's harms and hazards list, ensuring consistency in severity of harm determinations throughout the risk management process, pre- and post-market
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To contribute to departmental and cross-functional improvement initiatives belongs to your task area
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You promote safety awareness and a patient-centric mindset throughout the global Karl Storz organization