Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Job Title: Senior Clinical Safety Specialist

Department: Clinical and Medical Affairs

FLSA Status: Exempt

Position Overview:
This position will be responsible for implementing and executing clinical study safety activities. They will have primary responsibility for adverse event (AE) and device deficiency (DD) collection and safety management for clinical studies to ensure they are processed according the regulatory and internal timelines. They will collaborate with the clinical study team, assisting with safety-related questions and ensuring accuracy of safety data.

Responsibilities
• Manage accurate and timely safety reporting (AEs, SAEs, UADEs, DDs) per study and regulatory requirements
• Primarily responsible for tracking, triage and processing of incoming adverse events (AEs) and Device Deficiencies (DDs) including initial review to determine if expedited reporting may be required, follow-up of ongoing events, managing event adjudications, and/or coordination of returned devices for investigation, as necessary
• Collaborates with sites, monitors, Medical Monitor, Contract Research Organizations (CROs), and internal cross functional groups, as applicable, to ensure comprehensive information is available/provided/reported
• Responsible for the development and management of Clinical Events Committee (CEC) and/or Data Safety Management Board (DSMB), if applicable
• Distributes/notifies cross functional teams and clinical sites, of AEs/DDs, as appropriate
• Ensures Safety Management Plans are drafted and current with the protocol and regulatory requirements and compliance is maintained throughout the conduct of a clinical study
• Contribute to the development and implementation of clinical safety program initiatives, including supporting the development and management of safety related processes and procedures
• Draft and/or review AE narratives/safety information and support submission of safety information to applicable global regulatory authorities, Ethics Committees, Investigational Review Boards, etc. including but not limited to human research applications, waivers, safety reports, progress reports, final reports, requests for additional information, etc.
• Respond to internal requests for clinical safety information to support commercial license/approval submissions, publications and technical presentations, and post market surveillance activities, including event reconciliation between the clinical study and the Quality System complaint system (i.e. Trackwise), as needed
• Other clinical safety activities, as directed
• Participates in preparation activities and ensures clinical safety documentation is readily available for internal and external clinical related audits/inspections

Education and Experience
• Life sciences BA or BS degree or above.
Minimum Requirements include:
• 7+ years of related experience at medical device, biotechnology or contract research organization with direct experience in clinical research including global clinical safety adverse event management/reporting
• Proficiency in guidelines, standards and regulations that are applicable to medical devices and medical device clinical trials, including 21CFR803, 21CFR812, MDCG 2020-10/1, ISO 14155, EU MDR 2017, and ICH GCP

Preferred Skills and Competencies:
• Expertise in MS Word & Excel and PowerPoint
• Familiarity with electronic data capture (EDC) systems
• High attention to detail and degree of accuracy
• Demonstrated analytical skills and interpretation of regulations
• Excellent verbal and written communication skills
• Strong initiative, sense of urgency, and commitment
• Strong organizational skills with the capacity to prioritize and multi-task

Travel Requirements:
• This position requires some travel up to 10% of the time (domestic and international).

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote

Additional Information:
The US base salary range for this full-time position is $84,700.00 - $127,000.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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