Clinical Safety Scientist Medical Devices (m/f/d)

For our client, an international pharmaceutical company, we are currently looking for a Medical Device Clinical Safety Scientist.Location: BaselContract: 6 months (extension likely)Tasks & Responsibilities:Provide expert leadership and oversight for all clinical safety and vigilance activities associated with Class II and/or III Medical Devices (MD), ensuring adherence to global regulatory requirements and internal standards throughout the product lifecycle.Oversee and execute the MD vigilance process, including the intake, assessment, processing, and reporting of adverse events, ensuring timely and compliant submissions to regulatory bodies.Review core Medical Device study documentation to ensure comprehensive and accurate inclusion of safety-related content, including documents such as the Clinical Investigation Plan (CIP/Protocol) and Investigator’s Brochure (IB).Develop, maintain, and ensure the accuracy and timely updates of Reference Safety Information (RSI) for clinical investigations, incorporating emerging safety data and ensuring proper dissemination.Lead or significantly contribute to benefit-risk assessments for Medical Devices, providing expert analysis of clinical safety data to guide regulatory and strategic business decisions.Ensure the integration of MD risk management principles within clinical safety processes, aligning activities with ISO 14971 standards for risk management in medical devices.Act as the subject matter expert for all safety-related activities in MD clinical investigations.Maintain an advanced understanding of ISO 14155:2020 principles and apply them effectively to the design, execution, monitoring, documentation, and reporting of clinical investigations, with a strong focus on safety reporting and subject protection.Must-Haves:Bachelor’s, Master’s, or PhD in a scientific field.At least 3 years of relevant experience in healthcare, scientific research, or biomedical research focused on clinical safety, with hands-on experience in the use of MDs and/or combination products within the pharmaceutical, biotech, or medical device industries.Strong understanding of the technical and biomedical aspects of Medical Devices.Solid working knowledge of applicable regulations and industry standards for Medical Devices.Significant expertise in MD clinical investigations, with hands-on experience in safety activities related to Class II and/or III MD clinical investigations. Demonstrated ability to take on roles with safety responsibilities in MD clinical studies. Advanced understanding of ISO 14155:2020 and the ability to apply this standard effectively across all phases of MD clinical investigations. Proven capability to integrate ISO 14155 principles into practice. Experience in 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). Demonstrated ability to strategically lead the development of these deliverables independently. Demonstrable experience in MD benefit-risk assessments and practical application of risk management principles as per ISO 14971 standards. Familiarity with combination products (drug/MD).Direct experience in clinical safety and vigilance activities for Medical Devices.