Medical Safety Officer (m/f/d)

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%

Your Benefits

• Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required​
• 30 vacation days and various special payments​​
• Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more
• Corporate benefits and bicycle leasing​
• Subsidy for private pension plan and company health management​
• Various childcare options – at the headquarters in Tuttlingen​
• Health, sports, cultural and leisure activities – offers vary depending on location​