JETZT BEWERBEN
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a
Medical Device Clinical Safety Scientist
Background
Portfolio Clinical Safety provide safety science and vigilance to support to molecules and medical devices across the Roche portfolio. As a group, they are responsible for all aspects of safety science and vigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable / activity.
Tasks & Responsibilities
* Provide expert oversight and leadership for all clinical safety and vigilance activities for Class II and / or III Medical Devices (MD), ensuring compliance with global regulations and internal standards throughout the product lifecycle.
* Manage and execute the MD vigilance process, including the intake, processing, assessment, and reporting of adverse events, ensuring timely and compliant submissions to regulatory authorities.
* Review of core Medical Device study documentation to ensure robust inclusion of safety-related content. This includes, but is not limited to, the Clinical Investigation Plan (CIP / Protocol) and the Investigator’s Brochure (IB).
* Develop and maintain the Reference Safety Information (RSI) for clinical investigations, ensuring its accuracy, proper dissemination, and timely updates based on emerging safety data.
* Conduct and / or contribute significantly to Medical Device benefit-risk assessments, providing expert interpretation of clinical safety data to inform regulatory and business decisions.
* Ensure the practical application and integration of MD risk management principles within clinical safety processes, aligning activities with the requirements of ISO 14971 (Medical devices – Application of risk management to medical devices).
* Serve as the subject matter expert for all safety-related activities within MD clinical investigations.
* Maintain an expert-level understanding and ability to practically apply the principles of ISO 14155 : 2020 (Clinical investigation of medical devices for human subjects – Good clinical practice) to the design, conduct, monitoring, recording, and reporting of clinical investigations, specifically concerning safety reporting and subject protection.
* Provide guidance to clinical teams, investigators, and site staff on clinical investigation safety requirements, particularly those outlined in ISO 14155.
* Bachelor, Masters or PhD within the scientific fields
* Min. 3 years relevant Healthcare, Scientific or biomedical research background in clinical safety - with the use of MDs and / or combination products in the pharmaceutical / biotech or MD industry
* Strong understanding of the biomedical technical aspects of MDs
* Working knowledge of relevant MD regulations and industry standards
* MD clinical investigations expertise : significant expertise and hands‑on experience in safety activities related to (Class II and / or III) MD clinical investigations, evidenced by practical experience in roles with safety responsibilities in MD clinical investigations
* Expert‑level understanding and practical ability to apply ISO 14155 : 2020, and demonstrated strong ability to apply the standard in practice across all phases of MD clinical investigations
* Experience developing and providing safety input for core MD clinical investigation documents, including the Clinical Investigation Plan (CIP / Protocol), Investigator’s Brochure (IB), and Reference Safety Information (RSI), with demonstrated ability independently and strategically to lead the development of these deliverables for MD clinical investigations
* Risk Management : Demonstrable experience with MD benefit‑risk assessment and the practical application of MD risk management per ISO 14971
* Experience with combination products (drug / MD)
* Experience in Medical Device clinical safety and vigilance
* Excellent communicators, leadership, team player
Nice to Have
* Background in drug safety (pharmacovigilance) is an additional asset
What you will be offered
* An opportunity to work in one of the world's most important pharmaceutical companies
* Modern campus with plenty of green spaces and meeting areas
* Central location in Basel
* Varied job profile
* Further training opportunities through temptraining
* Working in a dynamic and motivated team
If you are interested please send your application documents addressed to Ms Diana Afonso.
Basel-Stadt Solothurn Aargau Safety Scientist MD Regulations Biomedical Investigations
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