Senior Clinical Development Lead (España)

Senior Clinical Development Lead (España)

07 sep
|
Roche
|
España

07 sep

Roche

España

Let’s build a healthier future, together By combining our unique strengths, we are redefining healthcare through sustainable action and innovation. For a behind-the-scenes look, check out this video to see how we at Roche are making personalized health care a reality. The mySugr GmbH was acquired by Roche in 2017 and our Vienna office is one of Roche's general 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 theSenior 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

📌 Senior Clinical Development Lead (España)
🏢 Roche
📍 España

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