Principal Clinical Safety Specialist- Shockwave Medical; Remote

Position: Principal Clinical Safety Specialist- Shockwave Medical (Remote)
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Product Safety
Job Sub Function:
Drug & Product Safety Operations
Job Category:
Professional
All Job Posting Locations:
Minnesota (Any City), Santa Clara, California, United States of America
Job Description:

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

Fueled by innovation at the intersection of biology and technology, we're 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. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

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 Committee(s) and Data Safety Monitoring Board(s).

Essential Job Functions

• Assumes wholistic 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 o 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) o Serving as liaison and advisor to the post-market surveillance team to resolve complaints related issues
  • Use of appropriate medical and regulatory judgement in escalating any safety concerns
• In addition, the Principal Clinical Safety Specialist may provide support for any of the following:
  • Review, evaluation of, and tracking of incoming adverse events (AEs) including follow-up of ongoing events o Collaboration with sites/monitors/Contract Research Organization (CRO) to ensure comprehensive information is available for full review of adverse events
  • Drafting or review of SAE narratives o Distribution and notification of AEs to appropriate teams and clinical sites, as needed o 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…