Senior Manager, Medical Safety
Core
Lead medical safety oversight for Interventional Oncology and Embolization therapies, ensuring safety vigilance and accurate assessment of adverse events throughout the product lifecycle.
Role type
Senior Manager, Medical Safety
Builds
Medical safety strategies, risk documentation, and post-market surveillance reports for interventional oncology devices.
Domain
Medical Device / Oncology / Interventional Radiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical safety oversight, adverse event assessment, risk management, team leadership, strategic planning, regulatory compliance (ISO/IMDRF/MedDRA)
Preferred skills
Oncology or interventional radiology clinical experience, advanced practice provider licensure, staff coaching, operational safety support
Technologies
MedDRA, IMDRF, ISO standards
Responsibilities
Ensure processes and training curriculum support medical safety oversight for clinical trials and quality complaints; Support risk documentation creation and updates, post-market surveillance reports, and clinical trial safety documents; Align medical safety strategy with the Medical Director and escalate emerging safety signals; Drive comprehensive analysis of potential safety issues throughout the product lifecycle; Represent Medical Safety in cross-functional working groups on patient safety matters; Manage resourcing needs and allocate resources to meet deadlines; Lead team through organizational change and process improvements.
Seniority
Senior Manager, hands-on leadership
