Sr. Clinical Safety Specialist

Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

The Sr. Clinical Safety Specialist is responsible for the clinical review and medical assessment of adverse events (AEs) and serious adverse events (SAEs) reported during Supira Medical's cardiovascular clinical trial. This individual applies clinical judgment to assess causality, expectedness, and severity; authors accurate and medically sound event narratives; and serves as the primary safety liaison to the Clinical Events Committee (CEC).

The role works in close, day-to-day partnership with Clinical Research Associates (CRAs) and site staff to ensure safety data is captured completely, accurately, and on time, and partners with the Sr VP of Medical and Clinical Affairs, Biostatistics, Data Management, and Regulatory Affairs to ensure the trial's safety surveillance meets FDA and ISO 14155 requirements.

• Adverse Event Review:
  Perform timely medical review of all reported AEs and SAEs for completeness, clinical accuracy, causality (relatedness to device and/or procedure), expectedness, and severity grading per the protocol and safety monitoring plan. Using MedDRA coding, code adverse events.
• Narrative Writing:
  Author clear, medically precise, and well-supported event narratives for individual case safety reports, DSMB packages, IDE annual/interim reports, and regulatory submissions.
• UADE Determination:
  Determine and document whether events meet criteria for Unanticipated Adverse Device Effects (UADEs) and ensure timely escalation and reporting to the Sr VP.
• CEC Liaison:
  Serve as the primary medical point of contact for the CEC: prepare and QC case packages, present cases at adjudication meetings, respond to committee queries, and track adjudication outcomes for consistency with protocol-defined endpoint definitions.
• CRA Partnership:
  Work daily with CRAs and site coordinators to ensure complete, accurate, and timely collection of AE/SAE source documentation; provide medical guidance on event follow-up, query resolution, and site-reported safety questions.
• Safety Data Reconciliation:
  Maintain reconciliation between the clinical database, CEC tracker, and safety database; identify and resolve discrepancies in event coding, dates, and outcomes.
• DSMB Support:
  Prepare aggregate safety summaries and data listings for DSMB reviews; respond to ad hoc safety signal requests and support risk-benefit assessments.
• Regulatory Compliance:
  Ensure adverse event and safety reporting activities comply with FDA regulations (21 CFR Parts 803, 812.150) and ISO 14155.
• Cross-Functional Collaboration:
  
  Partner with Data Management to develop CRFs and edit checks to ensure appropriate collection of necessary data elements; review safety data listings; support quality control of the safety database.
• Process & Training:
  Author and maintain CEC/DSMB Charters and the Safety Management Plan providing work instructions for AE/SAE processing, narrative writing, and CEC operations; train CRAs and site staff on AE reporting requirements and protocol safety definitions.
• Submission Support:
  Provide safety data summaries and…