Senior Manager, Medical Safety

About this role:

This role is responsible for the implementation of practices, policies, and processes for the Rhythm Management Medical Safety team to ensure medical expertise, objective oversight and safety vigilance throughout the total product lifecycle. The Medical Safety Manager II manages and facilitates the completion of accurate, timely, and consistent medical assessments of adverse events and potential adverse events. The Medical Safety Manager II provides leadership to 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 RM therapies.

Responsibilities will include:

• 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 the Quality organization and assists in the creation, implementation, and harmonization of standard policies and procedures.
• Recognize and directs organizational development needs and opportunities for continuous improvement within Medical Safety.
• Drive comprehensive, integrated analysis of a potential safety issue.
• Ensure early medical review of clinical trial Serious 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.

Required qualifications:

• Minimum of bachelor’s degree in healthcare/life science related field.
• Active licensure as an RN, DNP or PA
• Minimum of 8 years of direct patient care experience, electrophysiology or cardiology
• Minimum of 2 years of related work experience in Medical Safety, clinical research, and/or clinical quality.
• Strong leadership competencies – particularly communication, collaboration, planning, innovation, and strategic thinking.
• Excellent communication and people skills.

Preferred qualifications:

• Demonstrated proficiency in staff leadership and development.
• Experience in operational safety within clinical studies.