Senior Manager, Medical Safety

Job Description

Job Description

Position Summary:

This role is responsible for the implementation of practices, policies, and processes for the Interventional Oncology and Embolization Medical Safety team to ensure medical expertise, objective oversight and safety vigilance throughout the total product lifecycle. The Senior Manager, Medical Safety provides oversight, manages and facilitates the completion of accurate, timely, and consistent medical assessments of adverse events and potential adverse events. The Senior Manager, Medical Safety provides leadership to Medical Safety Professionals (non-MDs) to provide high level medical/ therapeutic guidance to internal and external customers. This role may also include individual contributor responsibilities related to Medical Safety oversight of sustaining Interventional Oncology and Embolization therapies and new product development.

Responsibilities:

• Ensure the processes and training curriculum are current to support medical safety oversight and input into Clinical (company 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
• Recognize and direct organizational development needs and opportunities for continuous improvement within Medical Safety
• In partnership with the Medical Director, this role aligns medical safety strategy, escalates emerging safety signals, and ensures consistent medical decision-making across the product lifecycle.
• Drive comprehensive, integrated analysis of a potential safety issue throughout the product lifecycle
• Ensure early medical review of clinical trial Adverse Events to identify unanticipated adverse device effects
• Represent Medical Safety in cross functional working groups on matters affecting patient safety in functional areas such as clinical studies, post market surveillance and risk management
• Serve as Acquisition Lead for Medical Safety, participating in integration work groups and identifying potential resourcing needs
• Manage resourcing needs of the team by maintaining key metrics and allocating resources to achieve feasible workloads and meet deadlines. May also include completing financial reports
• Leading through Change: With organizational change comes stress and uncertainty- provide support and leadership to analyst team through change and ongoing reorganization
• Work with leadership to identify work process changes/improvements, convey information to analyst team as available/appropriate

Required Qualifications:

• Holds current and active RN, NP, CRNP, DNP, or PA license
• Minimum of 8 years of experience providing direct patient care, preferably in oncology or interventional radiology.
• Minimum of 5 years of experience within the medical device, pharmaceutical, or related health care industry.
• Minimum of 2 years of experience leading, managing, or supervising clinical or professional staff.
• Demonstrated leadership skills, including communication, collaboration, strategic planning, innovation, and critical thinking

Preferred Qualifications:

• 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.