Clinical Safety Scientist Medical Devices

Vor 2 Tagen

Basel, Basel-Stadt, Schweiz Gi Group Vollzeit

For our client, an international pharmaceutical company, we are currently looking for a Medical Device Clinical Safety Scientist.

Location: Basel

Contract: 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.

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