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Medical Safety Officer

vor 1 Woche

Tuttlingen, Deutschland KARL STORZ Vollzeit

Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.

**Location**:Tuttlingen

**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, various professional development courses, and much more.
- Corporate benefits and bicycle leasing
- Subsidy for private pension plan and company health management
- Various childcare options Health, sports, cultural and leisure activities

Get in Contact
- Carolin Deschler