Senior Clinical Development Lead / Senior Medical Safety Physician (m/f/d)

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The mySugr GmbH was acquired by Roche in 2017 and our Vienna office is one of Roche's global sites. You will be located here, in the heart of Vienna, no matter if you work on a mySugr®, Accu-Chek®, navify® or any other Roche product or solution. You can read more about the history of mySugr & Roche here.

Here's what we're looking for:

Serving as a Clinical Development Lead and Medical Safety Physician, your primary role is to uphold the safety and integrity of all Roche-branded products. You oversee the full product safety lifecycle, ranging from premarket risk evaluations to postmarket complaint resolution. Core responsibilities include delivering timely Medical Risk Assessments, Health Hazard Evaluations, Risk Enablers, and criteria for Potential Reportable or Safety Issues, alongside providing key clinical guidance for postmarket issues. Working collaboratively with experts across R&D, premarket and postmarket quality, Clinical Development, and vigilance, you act as the core medical authority and participate in Safety Board meetings.

As the Senior Clinical Development Lead / Senior Medical Safety Physician you are an independent, conscientious professional and a dedicated team player with a strong commitment to quality. You bring an interdisciplinary mindset, adaptability, and the confidence to make critical decisions. You build alignment across functions with differing priorities and inspire a positive and collaborative spirit.

Your upcoming mission:

• Conduct Risk Analyses: Create comprehensive medical risk analyses (Health Hazard Evaluations, Medical Risk/Safety Assessments, and Safety Board meetings) to evaluate the clinical relevance of product complaints.
• Regulatory Communication: Process inquiries from international regulatory authorities related to adverse event reporting and product recalls.
• Expert Evaluations: Prepare internal and external medical safety evaluations and expert opinions for products across the Diagnostics portfolio (Core Lab, Molecular Lab, Near Patient Care, Diabetes Care).
• Process Optimization: Plan and conduct internal training sessions to optimize the operational interface between Customer Issue Resolution (CIR) and Medical Safety.
• Safety Board Medical Leadership: Represent Medical Safety in the internal Safety Board process, providing the medical assessment that informs board decisions.
• Documentation Compliance: Maintain and regularly update all procedural documents, guidelines, and SOPs/GSPs within your scope of responsibility.