Medical Safety Officer in Tuttlingen bei KARL STORZ

Your mission

• 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
• 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
• 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
• 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
• 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
• To contribute to departmental and cross-functional improvement initiatives belongs to your task area
• You promote safety awareness and a patient-centric mindset throughout the global Karl Storz organization

Your talents

• Medical degree or comparable education
• At least 5 years of clinical experience and 3 years of medical device industry and/or pharmaceutical experience
• Experience in risk evaluation and mitigation
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• Strong scientific analytical reasoning skills
• Ability to work on multiple complex projects in parallel
• English language skills required, German language skills would be an asset
• Willingness and ability to travel: up to 20%