Senior Cardiovascular Safety Specialist

Shifamed; Los Gatos (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

Supira Medical, a clinical-stage Shifamed Portfolio Company, is seeking a Sr. Clinical Safety Specialist in Los Gatos, CA to lead clinical review and medical assessment of AEs/SAEs in a cardiovascular trial.

The role partners with CRAs, site staff, and cross-functional teams to ensure safety data is complete, accurate, and compliant with FDA and ISO 14155 requirements; experience with CEC and IDE/PMAs is highly valued.

Qualifications

• Advanced clinical degree or license required; cardiology background preferred.
• 5+ years of experience in clinical safety, pharmacovigilance, or medical monitoring within medical devices, biotech, or pharma.
• Demonstrated experience authoring AE/SAE narratives for regulatory or clinical use.
• Direct experience with a Clinical Events Committee (CEC) or adjudication committee, including case preparation and presentation.
• Working knowledge of FDA device safety reporting requirements (21 CFR 803, 812.150) and ISO 14155.
• Familiarity with MedDRA coding and clinical/safety databases (e.g., Argus, ARISg).
• Strong clinical judgment and ability to assess causality and severity of complex cardiovascular events.

Responsibilities

• Adverse Event Review: perform timely medical review of AEs/SAEs for completeness, causality, and severity.
• Narrative Writing: author clear, medically precise narratives for regulatory submissions.
• UADE Determination: assess whether events meet UADE criteria and escalate as needed.
• CEC Liaison: serve as primary medical contact for the CEC and track adjudication outcomes.
• CRA Partnership: guide CRAs/sites on AE/SAE data collection and safety questions.
• Safety Data Reconciliation: reconcile data between databases and listings; resolve discrepancies.

Skills

Adverse Event Review

Narrative Writing

UADE Determination

CEC Liaison

CRA Partnership

Safety Data Reconciliation

DSMB Support

Regulatory Compliance

Cross-Functional Collaboration

Process & Training

Submission Support

Education

Advanced clinical degree or license (MD/DO/NP/PA/RN)

Job description

Supira Medical, a clinical-stage Shifamed Portfolio Company, is seeking a Sr. Clinical Safety Specialist in Los Gatos, CA to lead clinical review and medical assessment of AEs/SAEs in a cardiovascular trial.

The role partners with CRAs, site staff, and cross-functional teams to ensure safety data is complete, accurate, and compliant with FDA and ISO 14155 requirements; experience with CEC and IDE/PMAs is highly valued.