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 www.supiramedical.com.
Description:
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.
Responsibilities, Skills & Hands-On Experience:
- 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 narratives supporting IDE supplements, PMA submissions, and FDA interactions as needed.
Education & Work Experience:
- Advanced clinical degree or license (MD, DO, NP, PA, or RN) or equivalent clinical training; cardiology or cardiovascular clinical background strongly preferred.
- 5+ years of experience in clinical safety, pharmacovigilance, or medical monitoring within the medical device, biotech, or pharmaceutical industry.
- Demonstrated experience independently authoring AE/SAE narratives for regulatory or clinical use.
- Direct experience working 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 database systems (e.g., EDC-integrated safety modules, Argus, ARISg, or similar).
- Strong clinical judgment and ability to independently assess causality and severity of complex cardiovascular adverse events.
- Excellent written communication skills, with meticulous attention to medical and regulatory accuracy.
- Comfortable working closely and collaboratively with CRAs, clinical operations, and site staff on a day-to-day basis.
- Experience with mechanical circulatory support, structural heart, high-risk PCI, or other Class III cardiovascular devices, preferred.
- Experience supporting an IDE pivotal trial from first enrollment through PMA submission, preferred.
- Board certification in cardiology, cardiac surgery, or a related subspecialty (if MD/DO), preferred.
- Experience at an early-stage or venture-backed medical device company, preferred.
Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $120,000 to $150,000 + equity + benefits.
