Senior Clinical Safety Analyst

2 weeks ago

Minneapolis, Minnesota, United States Shockwave Medical Full time


Shockwave Medical is an innovative medical device organization dedicated to transforming the management of advanced cardiovascular conditions. Following the recent integration of Neovasc and their groundbreaking Reducer System, we are expanding our capabilities to provide new solutions for patients and healthcare providers dealing with refractory angina—a persistent and debilitating chest pain that is unmanageable through conventional treatments and surgical interventions, impacting millions globally. Our mission is to alleviate the suffering of these patients and enhance their overall quality of life.

Position Overview

The Senior Clinical Safety Analyst will play a pivotal role in the collection, processing, and reporting of adverse events, collaborating closely with Regulatory Affairs and Post-Market Surveillance teams. This position requires independent management to ensure that all adverse events are handled in accordance with regulatory and internal timelines, encompassing intake, triage, narrative development, and quality assurance. The Senior Clinical Safety Analyst will also be involved in the preparation and management of Clinical Events Committee meetings and Data Safety Monitoring Board meetings. Furthermore, this role includes maintaining study-specific Safety Management Plans and contributing to the writing and review of safety sections in clinical study documents.

Key Responsibilities
  • Review and track incoming adverse events (AEs), including follow-up on ongoing cases.
  • Collaborate with sites, monitors, and Contract Research Organizations (CROs) to ensure comprehensive data is available for thorough AE reviews.
  • Work alongside Regulatory Affairs, Clinical Affairs, and the Medical Director on events that necessitate expedited evaluation or reporting.
  • Draft detailed AE narratives.
  • Ensure timely distribution and notification of AEs to relevant teams and clinical sites as necessary.
  • Act as a liaison for safety-related inquiries from Clinical Affairs, CROs, monitors, Field Clinical Specialists, and post-market quality surveillance.
  • Coordinate and participate in the preparation for Clinical Events Committee (CEC) and Data and Safety Monitoring Board (DSMB) meetings.
  • Guarantee consistency and compliance in the application of protocol definitions for adjudication outcomes.
  • Stay informed about current FDA, ISO, and other regulatory rules and policies affecting AE reporting.
  • Maintain up-to-date Safety Management Plans in line with protocol and regulatory requirements.
  • Contribute to the development and management of study-related documents, including clinical protocols, case report forms, monitoring plans, and other tools pertinent to adverse event reporting.
  • Assist in the preparation of safety reporting for annual reports, clinical study reports, and investigator brochure updates.
  • Support training initiatives for study personnel regarding adverse event definitions as per protocol.
  • Provide input for planning and preparing materials for presenting adverse event information at investigator and coordinator meetings.
  • Collaborate on additional Clinical Affairs activities as required.
  • Perform other duties as assigned.
Qualifications
  • Registered Nurse (RN) or equivalent healthcare experience with a Bachelor's degree in life sciences preferred.
  • A minimum of 5+ years of clinical research experience, particularly in clinical safety and adverse event management.
  • Experience in the field of cardiovascular disease.
  • Prior involvement with medical device clinical studies is advantageous.
  • Excellent written, verbal, and interpersonal communication skills, with a strong grasp of medical terminology.
  • Proficient in computer applications (Microsoft Word, Excel, PowerPoint, etc.).
  • Strong organizational skills with a keen attention to detail.
  • Familiarity with electronic data capture (EDC) systems.
  • Able to work effectively both independently and as part of a team, with flexibility to adapt to changing requirements.
  • Experience in coordinating, prioritizing, and managing multiple tasks and timelines.
  • In-depth knowledge of medical device regulations and compliance guidelines for clinical studies, including Good Clinical Practice (GCP) and relevant guidance documents (ICH, ISO, FDA, etc.).
  • This position may require occasional travel.
Compensation and Benefits
Shockwave Medical offers a competitive compensation package along with a comprehensive benefits program, including:

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, Life Insurance, Employer contributions toward Health Savings Account (HSA), and a competitive PTO balance.

Additional Perks: Employee Stock Purchase Plan (ESPP), Calm App subscription, Pet Insurance, Student Loan Refinancing options, and Spot Bonus awards.

Equal Employment Opportunity Employer

  • Senior Financial Analyst

    2 weeks ago

    Minneapolis, Minnesota, United States Hennepin County MN Full time

    Position Overview:The Housing and Economic Development division is in search of a Senior Financial Analyst who will engage in advanced accounting tasks associated with the management of departmental, grant, and housing redevelopment initiatives.Key Responsibilities:- Execute high-level accounting functions to support various projects.- Collaborate with...

  • Senior Financial Analyst

    2 weeks ago

    Minneapolis, Minnesota, United States Fricke Recruiting Full time

    Fricke Recruiting Services - New CFA CandidateAt Fricke Recruiting Services, we focus on identifying outstanding CFA professionals for a variety of financial roles. We are currently in search of a skilled individual to take on the position of CFA Investment Analyst & Accountant Candidate.Job Title Options:AnalystAssociateInvestment AccountantAccounting...

  • Senior Financial Insights Analyst

    2 weeks ago

    Minneapolis, Minnesota, United States Creative Financial Staffing Full time

    Senior Financial Insights Analyst Overview We are seeking a highly skilled and motivated financial analyst to take on the role of Senior Financial Insights Analyst within our organization. This position is ideal for individuals who are passionate about driving business success through financial analysis and strategic planning. In this capacity, you will play...

  • Senior IT Business Analyst

    2 months ago

    Minneapolis, Minnesota, United States CliftonLarsonAllen Full time

    CLA is a top 10 national professional services firm where our purpose is to create opportunities every day, for our clients, our people, and our communities through industry-focused wealth advisory, digital, audit, tax, consulting, and outsourcing services. Even with more than 8,500 people, 130 U.S. locations, and a global reach, we promise to know you and...

  • Senior Analyst in Business Operations

    2 weeks ago

    Minneapolis, Minnesota, United States Optum Full time

    Company OverviewOptum is a worldwide organization dedicated to enhancing healthcare through technology, assisting millions in achieving healthier lifestyles. Our team is committed to improving health outcomes by linking individuals with essential care, pharmacy benefits, data, and resources. We foster a culture rooted in diversity and inclusion, with...

  • Senior Transportation Security Inspector

    5 days ago

    Minneapolis, Minnesota, United States Transportation Safety Administration Full time

    Job SummaryWe are seeking a highly skilled and experienced Transportation Security Inspector to join our team at the Transportation Safety Administration. As a Senior Specialist, you will play a critical role in ensuring the security and integrity of our nation's transportation systems.Key ResponsibilitiesConduct complex security inspections and...

  • Senior Financial Analyst

    3 weeks ago

    Minneapolis, Minnesota, United States Best Buy Full time

    As a Senior Financial Analyst, you'll act as a subject matter expert within your specific capability of One Finance. You will support areas including category merchants, sales channels, services, supply chain, capital planning and enterprise financial planning and analysis. Over time, you'll have the opportunity to change the area you support to continue...

  • Senior Development Analyst

    1 month ago

    Minneapolis, Minnesota, United States Mortenson Construction Full time

    ABOUT MORTENSONAs a Top 25 builder, developer, and EPC, our expertise spans markets like sports, renewable energy, data centers, healthcare, and more. We are builders at heart, working to ensure the built environment has a lasting positive impact. Let's Redefine Possible SUMMARYMortenson Development, Inc. (MDI) is seeking a Senior Development Analyst to be...

  • Senior Technical Business Analyst

    1 week ago

    Minneapolis, Minnesota, United States Search Leaders, LLC Full time

    Job OverviewSalary: $120,000-$135,000Position: Senior IT Business AnalystLocation: HybridSearch Leaders, LLC is a prominent player in the petrochemical manufacturing and distribution sector, committed to an employee-centric and customer-oriented philosophy. Our mission is to enhance the quality of life for our employees, clients, and communities through...

  • Senior Compliance Analyst, Licensing

    2 weeks ago

    Minneapolis, Minnesota, United States Adtalem Global Education Full time

    Company OverviewAbout Adtalem Global EducationAdtalem Global Education stands as a prominent entity in the realm of post-secondary education, recognized for its pivotal role in supplying skilled professionals to the healthcare sector. Our mission is to equip and inspire students with the essential knowledge and skills to emerge as influential leaders within...

  • Senior Compliance Analyst, Licensing

    2 weeks ago

    Minneapolis, Minnesota, United States Adtalem Global Education Full time

    Company OverviewAbout Adtalem Global EducationAdtalem Global Education stands as a prominent entity in the realm of post-secondary education, recognized for its pivotal role in supplying skilled professionals to the healthcare sector. Our mission is to educate and empower individuals, equipping them with the essential knowledge and skills to emerge as...

  • Senior Compliance Analyst, Licensing

    2 weeks ago

    Minneapolis, Minnesota, United States Adtalem Global Education Full time

    Company OverviewAbout Adtalem Global EducationAdtalem Global Education stands as a prominent entity in the realm of post-secondary education, recognized for its role as a leading provider of professional talent within the healthcare sector. Adtalem is dedicated to educating and empowering students, equipping them with the essential knowledge and skills to...

  • Senior Financial Analyst

    6 hours ago

    Minneapolis, Minnesota, United States Abbott Laboratories company Full time

    About Abbott LaboratoriesAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people...

  • Senior Analyst for Business Solutions

    2 weeks ago

    Minneapolis, Minnesota, United States Optum Full time

    About OptumOptum is a global leader in healthcare solutions, leveraging technology to enhance the well-being of millions. By joining our team, you will contribute to improving health outcomes by connecting individuals with essential care, pharmacy benefits, data, and resources. Our culture is rooted in diversity and inclusion, with talented colleagues,...

  • Senior Financial Analyst

    7 days ago

    Minneapolis, Minnesota, United States General Mills Full time

    Senior Financial AnalystWe are seeking a highly skilled Senior Financial Analyst to join our Mergers & Acquisitions (M&A) Team at General Mills, a leading food company. This role is part of the Finance organization and will work closely with business leaders and cross-functional partners to develop financial models and analyze data.Key ResponsibilitiesEngage...

  • Senior Tax Analyst

    5 days ago

    Minneapolis, Minnesota, United States Creative Financial Staffing Full time

    Job Summary:We are seeking a highly skilled Senior Tax Analyst to join our team at Creative Financial Staffing. As a Senior Tax Analyst, you will play a crucial role in supporting both income tax and sales tax functions within the organization.Key Responsibilities:Financial Analysis: Prepare and review income tax provisions and related compliance...

  • Senior Business Systems Analyst

    2 weeks ago

    Minneapolis, Minnesota, United States UnitedHealth Group Full time

    About UnitedHealth Group:UnitedHealth Group is a leading global organization committed to enhancing healthcare through innovative technology and comprehensive services. We strive to empower individuals to lead healthier lives.Role Overview:We are looking for a dedicated Senior Business Systems Analyst to join our dynamic Marketing Technology team. In this...

  • Clinical Data Analyst

    5 days ago

    Minneapolis, Minnesota, United States Emergency Physicians Professional Association Full time

    Job OpportunityWe are seeking a skilled Clinical Data Analyst to join our team at Emergency Physicians Professional Association.Job SummaryThe successful candidate will be responsible for providing accurate and efficient coding services for emergency department and ambulatory acute care facilities.Key ResponsibilitiesPerform coding tasks with a high degree...

  • Senior Financial Analyst

    1 week ago

    Minneapolis, Minnesota, United States Pritchard Auto Company Full time

    Job OverviewJoin Our Dynamic Team!Pritchard Auto Company is a family-operated business with a legacy spanning multiple generations. We are committed to expanding our influence in the transportation sector and are seeking talented individuals to contribute to our ongoing success.Position: Senior Financial Analyst – Financial Planning & AnalysisWe are on the...

  • Transportation Security Inspector

    5 days ago

    Minneapolis, Minnesota, United States Transportation Safety Administration Full time

    Job SummaryWe are seeking a highly skilled and experienced Transportation Security Inspector to join our team at the Transportation Safety Administration. As a Senior Specialist, you will play a critical role in ensuring the security and integrity of our nation's transportation systems.Key ResponsibilitiesConduct complex security inspections and...