Safety Program Specialist II - AFZ

About the role

The Safety Program Specialist II supports the oversight and management of clinical trial safety activities for investigational and marketed medical devices within the Rhythm Management division. The role covers adverse event and device deficiency assessment, safety reporting, and the development and execution of study-specific safety plans, working with cross-functional teams to deliver timely, accurate and compliant safety outputs.

Key responsibilities

• Develop, maintain and execute study-specific safety plans and supporting documentation such as Safety Plans, Complaint Plans and CEC/IMR Charters.
• Evaluate adverse events and device deficiencies and determine their assessment, processing and reporting requirements.
• Coordinate and oversee safety event processing, including data review, query resolution and reporting timelines.
• Support clinical and medical assessment of safety events with designated medical reviewers.
• Represent Clinical Trial Safety on cross-functional clinical study teams and coordinate Safety Review meetings, including follow-up on action items.
• Coordinate safety event adjudication and reconciliation to support study milestones and data quality.
• Provide safety input into clinical study documents and processes, including protocol development and CRF design.
• Identify and escalate safety concerns, data quality issues and process gaps to stakeholders in a timely manner.
• Ensure timely delivery of safety outputs and support departmental initiatives and process improvements.

Required profile

• Bachelor's degree in nursing, life sciences, healthcare or a related field, or an equivalent combination of education and experience.
• Minimum of two years of relevant experience in clinical research, medical devices, clinical trial operations or clinical safety.
• Preferred: experience with clinical trial safety management, including adverse event and device deficiency assessment, processing and reporting.
• Preferred: knowledge of medical device clinical research regulations and standards, including ISO 14155, 21 CFR Part 812 and GCP; familiarity with clinical data management systems, safety databases and EDC systems.
• Preferred: knowledge of cardiac rhythm management, electrophysiology or Watchman therapies.

Required skills

• Analytical and critical thinking skills to evaluate complex clinical safety information.
• Effective written and verbal communication and collaboration with cross-functional stakeholders.
• Organizational and prioritization skills to manage multiple studies, competing priorities and deadlines.
• Ability to work independently, exercise sound judgment and escalate safety issues appropriately.
• Attention to detail and commitment to data quality, regulatory compliance and timely execution.