Senior Specialist, Clinical Safety

Job Details:

Job Location:

Irvine, CA 92618, Position Type:
Full Time, Education Level: 4 Year Degree, Salary Range: $ - $ Salary/year,

Job Shift: 1st Shift,

Job Title:

Senior Specialist, Clinical Safety

Role Level: Individual Contributor (IC)

Supervisor/Manager

Title:

Senior Manager, Clinical and Medical Safety

Job Location & Environment:
Irvine, CA – Corporate Office or Remote

Reporting to the Senior Manager, Clinical Safety, the Senior Specialist, Clinical Safety independently manages a high volume of concurrent safety activities across multiple active Jena Valve clinical trials, including the ARTIST Trial, ALIGN-AR Pivotal Trial, ALIGN-AR EFS Trial, and the JENA-VAD Registry. This role requires the ability to manage a demanding, fast-moving workload across overlapping study timelines and deadlines, while maintaining a high level of accuracy and regulatory compliance.

The Senior Specialist takes a lead role in adverse event reporting, CEC/DSMB support, and safety documentation for regulatory submissions, and serves as a subject matter resource and mentor to other members of the Clinical Safety team.

• Independently manage a high-volume, concurrent safety caseload across multiple active clinical studies with overlapping deadlines; prioritize competing demands with minimal oversight.
• Conduct assessments of adverse events (AEs) and complaints across multiple clinical studies, including UADE (Unanticipated Adverse Device Effect) determinations; perform complaint handling assessments and report AEs per regulatory requirements, trial safety processes, and Jena Valve procedures.
• Review and analyze aggregate safety reports to identify early safety signals; proactively elevate findings to leadership with recommended next steps.
• Track timeliness of AE and SAE reporting by investigational sites and follow up as needed to ensure compliance with protocol-specified timelines across multiple concurrent studies.
• Interact with investigational sites and field monitors to obtain additional pertinent information on Case Report Forms and medical documentation (source documents).
• Independently prepare, review, and finalize event narratives and safety data packages for internal review and external reviews (e.g., Clinical Events Committee, Data Safety Monitoring Board) and for regulatory submissions, including IDE Annual Progress Reports.
• Own the safety sections of IDE Annual Progress Reports and other major regulatory submissions end-to-end, including data reconciliation, MedDRA coding oversight, and CEC adjudication status tracking, under tight submission timelines.
• Build and deliver recurring and ad hoc safety presentations and dashboards for leadership, DSMB, and CEC audiences, condensing high volumes of safety data into clear, decision-ready materials.
• Serve as a subject matter resource for the MedDRA coding team on complex coding questions; participate in and help lead MedDRA coding team meetings.
• Provide clinical and medical subject matter expertise to address safety-related questions from internal study teams, field support personnel, monitors, and study sites across concurrent studies.
• Contribute to clinical aspects of protocol development, including drafting the Safety section of clinical trial protocols, adverse event definitions, AE reporting requirements, and risk sections.
• Collaborate with data management and cross-functional teams on the development of case report forms, study-specific safety reports, and other study forms, ensuring alignment with clinical definitions and EDC data flows.
• Support DSMB and CEC startup and ongoing management activities, including vendor selection and approval, member selection, charter development, and meeting materials.
• Respon…