Senior Patient Safety Training Manager

At Novo Nordisk, the Clinical, Medical and Regulatory (CMR) department is a diverse and collaborative group focused on improving patients' quality of life. From healthcare provider interactions and regulatory strategy development to medical education and data collection for new product development, CMR maintains a patient-centered approach. This role contributes to global patient impact by driving innovation in patient safety and training.

About the role

Lead and govern the end-to-end Patient Safety training strategy for onboarding and on-the-job training across pharmacovigilance and Safety functions, including internal teams and external vendors. Serve as a key decision maker in strategy discussions with Patient Safety leadership and cross-functional stakeholders, ensuring oversight of vendor training processes, compliance, and corrective actions.

Responsibilities

• Provide full oversight and governance of vendor training processes, including strategy, standards, and lifecycle management (design, onboarding, delivery, updates, and performance monitoring).
• Develop and maintain vendor training procedures, governing documents (e.g., SOPs, training standards, qualification criteria), and ensure alignment with Patient Safety leadership and Subject Matter Experts (SMEs).
• Lead strategy discussions and decision-making for vendor training priorities, methodologies, escalation paths, and risk-based approaches.
• Maintain expertise in Safety database systems, reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines, and Good Clinical Practice (GCP) to ensure compliance.
• Collaborate with Patient Safety Management to retrain employees on specific objectives and provide feedback as needed.
• Develop quality checkpoints to track and evaluate training progress, providing assessment feedback to employees and managers.
• Identify training gaps, recommend solutions, and lead implementation for internal and external safety staff and suppliers.
• Support development and maintenance of Patient Safety eLearning modules on the Learning Management System (LMS).
• Serve as an SME on Safety database systems, SOPs, FDA guidelines, and GCP, translating requirements into training and operational best practices.
• Ensure training governance documentation (including vendor records) is controlled, versioned, and audit-ready.
• Stay updated on regulations and guidelines from FDA, Health Canada, ICH, and other industry sources.
• Review training-related deviations and CAPAs, supporting corrective actions to ensure timely closure.
• Support inspection readiness by maintaining training records, SOP updates, and evidence of competency.
• Plan and implement automated solutions to improve daily operations, including metric tracking.
• Identify areas for automation and improvement in GxP Compliance & Patient Safety training processes (e.g., vendor oversight, project trackers, mailbox management).
• Evaluate and implement tools/technologies to streamline processes and support employee onboarding and continuous learning.
• Add operational efficiencies through AI and automation solutions for compliance reporting.

Requirements

• A Bachelor’s Degree in Nursing, Pharmacy, or a medical/science-related discipline (relevant experience may substitute for degree).
• Experience in Pharmacovigilance training or mentorship is preferred.
• Knowledge of medical terminology.
• Excellent presentation, interpersonal, and stakeholder management skills, with demonstrated ability to influence cross-functional teams and lead training initiatives.
• GxP compliance training and oversight reporting experience.
• High proficiency in PowerPoint, Word, Outlook, and Excel.
• Experience with automation and artificial intelligence tools.
• Strong project management skills with the ability to manage multiple projects.
• Creative and experienced in content creation.

Schedule

This is a remote-based position located anywhere in the United States, with approximately 10% overnight travel required.

Pay

The base compensation range for this position is $120,000 to $180,000, determined by experience and other factors. This role is also eligible for a company bonus based on individual and company performance, as well as long-term incentive compensation.

Benefits

• Medical, dental, and vision coverage.
• Life insurance and disability insurance.
• 401(k) savings plan with company match.
• Flexible spending accounts (FSA).
• Employee assistance program (EAP).
• Tuition reimbursement program.
• Voluntary benefits, including group legal, critical illness, identity theft protection, and pet insurance.
• Paid time off, including sick leave, flexible vacation, and parental leave.