Principal Clinical Safety Specialist- Shockwave Medical; Remote

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Product Safety

Drug & Product Safety Operations

Professional

Minnesota (Any City), Santa Clara, California, United States of America

Johnson & Johnson is hiring for a Principal Clinical Safety Specialist – Shockwave Medica to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

We are developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

The Principal Clinical Safety Specialist will have primary responsibility for study or program oversight, ensuring all aspects of safety are conducted according to procedure and in a compliant manner. The Principal Clinical Safety Specialist may oversee one or more studies, assuming ownership for study‑specific requirements. This may include special projects, process development, vendor oversight, audit participation, and providing advisory to the clinical and post‑market surveillance teams.

In addition, the Principal Clinical Safety Specialist will be responsible for providing backup support for adverse event collection and processing, safety monitoring, maintenance of study‑specific Safety Management Plans, and participation in writing and/or reviewing safety sections of clinical study documents. This may also include management of Clinical Events Committees (CEC) and Data Safety Monitoring Boards (DSMB).

• Assumes holistic responsibility for safety management and monitoring for one or more clinical studies, including:
  • Establishment of end‑to‑end safety documentation system; development of study‑specific plans, procedures and data entry guidelines
  • Compliance with pre‑market regulatory reporting of serious adverse events (SAEs) and device deficiencies (DDs)
  • Assurance of high‑quality safety data collection and provision of direction and guidance to safety vendor(s), escalating vendor management issues as appropriate
  • Management of Clinical Events Committees (CEC) and Data and Safety Monitoring Boards (DSMB); serving as liaison and advisor to the post‑market surveillance team to resolve complaints related issues
  • Use of appropriate medical and regulatory judgment in escalating any safety concerns
• In addition, may provide support for any of the following:
  • Review, evaluation of, and tracking of incoming adverse events (AEs) including follow‑up of ongoing events; collaboration with sites/monitors/CRO to ensure comprehensive information is available for full review of adverse events
  • Drafting or review of SAE narratives; distribution and notification of AEs to appropriate teams and clinical sites, as needed; liaison for safety‑related questions from Clinical Affairs, CRO, monitors, Field Clinical Specialists, post‑market quality, surveillance, etc.
  • Verification of consistency and compliance in application of protocol definitions for adjudication outcomes
  • Providing input to the development and management of study‑related documents including clinical protocols, case report forms, monitoring plans, study manuals, and other study tools related to adverse event reporting and definitions
  • Assistance with preparation of safety reporting for annual reports,…