Principal Clinical Safety Specialist- reputed company (Remote)

At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, reputed company 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 reputed company, 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 reputed company Job Posting Locations: Minnesota (Any City), Santa Clara, California, United States of America Job Description: reputed company is hiring for a Principal Clinical Safety Specialist- reputed company to join reputed company. The position is FULLY REMOTE and can sit reputed company in the US. At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we're developing the reputed company 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 reputed company calcified cardiovascular disease. Our reputed company 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 reputed company, ensuring reputed company aspects of safety are conducted according to procedure and in a compliant manner. The Principal Clinical Safety Specialist may reputed company one or more studies, assuming ownership for study-specific requirements. This may include special projects, process development, vendor reputed company, 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 reputed company 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 (reputed company) 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 reputed company to appropriate teams and clinical sites, as needed o Liaison for safety-reputed company 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 reputed company documents including clinical protocols, case report forms, monitoring plans, study manuals, and other study tools reputed company to adverse event reporting and definitions
• Assistance with preparation of safety reporting for annual reports, clinical study reports, investigator brochure updates, and other documents as required
• Maintains knowledge of reputed company FDA, ISO, competent authority, IRB, REB, and EC regulatory rules and policies affecting AE reporting
• Assists in training of study personnel regarding the adverse event definitions per protocol
• Collaborates on additional Clinical Affair's activities, as required
• Other duties as assigned

Qualifications

• RN or equivalent healthcare experience, with Bachelor's degree preferred
• Minimum 10+ years' experience in clinical safety or combined clinical safety/post-market vigilance experience, with prior clinical research experience preferred
• Experience in cardiovascular disease preferred
• Experience with medical device clinical studies preferred
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
• Proficient computer skills (reputed company Word, reputed company, PowerPoint, etc.)
• Good prioritization and organizational skills
• High attention to detail and degree of accuracy
• Familiarity with electronic data capture (reputed company) systems
• Operates both as a team and independently, with adaptability to changing requirements
• Experience coordinating, prioritizing, setting timelines, and multi-tasking
• Expertise with medical device regulations and compliance guidelines for clinical studies including ISO 14155, 21 CFR 812, EU MDR and other relevant guidance documents
• Position requires approximately 10% travel

reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. reputed company is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Advanced Analytics, Analytical Reasoning, Clinical Operations, Communication, Critical Thinking, Medicines and Device Development and Regulation, OSHA Compliance, Problem Solving, Process Oriented, Quality Control (QC), Risk Compliance, Safety Investigations, Safety-Oriented, Scientific Research, Serious Adverse Event Reporting, Standard Operating Procedure (SOP) The anticipated reputed company pay range for this position is : $125,000.00 - $201,250.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the reputed company -48 hours per calendar year; for employees who reside in the reputed company -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours reputed company one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits Apply tot his job Apply To this Job