Senior Manager, Medical Safety

Your responsibilities will include: Ensure the processes and training curriculum are current to support medical safety oversight and input into Clinical (BSC sponsored clinical trials) and Quality (product complaint handling) Support risk documentation creation and updates, post-market surveillance reports, clinical trial safety documents Support the Quality organization and assist in the creation, implementation, and harmonization of standard policies and procedures Ensure early medical review of clinical trial Adverse Events to identify unanticipated adverse device effects Manage resourcing needs of the team by maintaining key metrics and allocating resources to achieve feasible workloads and meet deadlines. Work with leadership to identify work process changes/improvements, convey information to analyst team as available/appropriate Holds current and active RN, NP, CRNP, DNP, or PA license Minimum of 8 years' experience providing direct patient care, preferably in oncology or interventional radiology. Minimum of 5 years' experience within the medical device, pharmaceutical, or related health care industry. Minimum of 2 years' experience leading, managing, or supervising clinical or professional staff. Demonstrated leadership skills, including communication, collaboration, strategic planning, innovation, and critical thinking Proven experience as an oncology, interventional radiology, critical care nurse, or advanced practice provider. Demonstrated proficiency in staff leadership, coaching, and professional development. Experience supporting operational safety activities for clinical studies and medical devices. Knowledge of ISO standards, IMDRF coding, and MedDRA coding practices.