AtriCure, Inc. · 7 hours ago
Safety Specialist II
Minnetonka, 130 Cheshire Lane, Minnetonka, Minnesota, United States of America
Full-time
Onsite
Entry, Mid Level
$89K/yr - $148K/yr
2+ years expAtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Safety Specialist II will be responsible for safety-related aspects of clinical trials, coordinating and managing safety processes in compliance with regulations and protocols.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Ensures compliance and adherence to safety aspects for assigned clinical trials including collection, processing, coding and tracking of (Serious) Adverse Events (AE/SAE) reports and adverse event documentation including safety narratives
Coordinates and manages reconciliation of AE/SAEs, preparing cases for adjudication, writing event narratives, cleaning data, coding Medical Dictionary for Regulatory Activities (MedDRA) etc
Participates in the development of safety sections for documents such as clinical trial protocols, informed consents, case report forms, site selection materials, data collection and reporting instructions, investigator updates and other project-specific documents required for the conduct of assigned studies in accordance with current applicable regulations, good clinical practices (GCPs), and industry best practices pertaining to safety
Provides input to and reviews the SMP and other materials required for conduct, and maintenance of assigned clinical studies for assigned studies in accordance with applicable regulations and best practices pertaining to safety
Provides input toward SOP and WIs for the Clinical Affairs department
Provides input in the review of interdisciplinary study-specific documents for consistency and compliance
Ensures timely reporting of AEs, SAEs and UADE’s, in accordance with applicable regulations, protocols, and company procedures
Ensures integrity and quality of safety data including reconciliation of safety data listings
Qualification
Required
Bachelor's degree or equivalent is required
Minimum of two years of clinical safety experience is required
Proficient knowledge of Microsoft® Office suite
Experience with writing of safety narratives
Working knowledge of MedDRA terminology and its application
Familiarity with EDC systems (e.g. Clindex)
Skilled at working effective in a collaborative team environment
Independently motivated, detail oriented, analytical and strong problem-solving ability
Knowledge and understanding of FDA and Global Regulations and Guidelines for the conduct of clinical trials
Ability to exercise judgment and determine appropriate action
Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment, and manage competing deadlines
Exceptional verbal and written communication skills
Preferred
Previous experience in Medical Safety, Clinical Research, and/or working with a Medical Device Sponsor company or CRO
Experience with safety monitoring in medical device industry
Previous experience working as a safety specialist within a cardiology therapeutic area
Demonstrated success in collaborating with and communicating effectively across different functions
Benefits
Medical & Dental beginning day 1 of employment
401K plus match
20 days of paid Parental Leave
Maternity leave
Volunteer Time off
Pet Insurance
Full access to our on-site fitness center and cafeteria
Company
AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide.
1001-5000 employees
H1B Sponsorship
AtriCure, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (7)
2022 (10)
2021 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$201MKey Investors
U.S. Venture Partners
2020-05-12Post Ipo Equity· $175M
2005-08-05IPO
2002-06-10Series Unknown· $21M
Leadership Team
Michael H. Carrel
President and Chief Executive Officer
Tamer Ibrahim
Vice President, Research & Technology
Recent News
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