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.
Must Haves:
- 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