The Position

Responsible for leading and governing the end-to-end Patient Safety training strategy and oversight for onboarding and on-the-job training for pharmacovigilance/Safety functions, including internal and external (vendor) training governance. Serves as a key decision maker and leads strategy discussions with Patient Safety leadership and cross-functional stakeholders. Ensures full oversight of vendor training processes, including development, implementation and maintenance of training procedures, governing standards and strategy for vendor qualification and ongoing training performance.

Leads accountability for training-related deviations and corrective actions impacting vendor training processes. Supports and maintains inspection readiness for the training function, including participation as a member of the inspection team. Ensures compliance with Federal regulations and company SOPs regarding collection, verification and maintenance of adverse events (AE), device incidents, technical complaints and other safety information for all Novo Nordisk products.

Relationship

This job reports to the Director of the GxP Compliance & Patient Safety Training. Internal relationships include senior Patient Safety personnel and cross-functional partners (e.g., Quality, Compliance, PV Ops, LMS/Learning, Vendor Management/Procurement where applicable). External relationships include training vendors and other suppliers for Safety training governance, performance oversight and training corrective action follow-up.

Essential Functions

• Compliance Training
  • Provide full oversight and governance of vendor training processes, including strategy, standards and lifecycle management (design, onboarding/activation, delivery oversight, periodic updates and performance monitoring).
  • Develop and maintain vendor training procedures and governing documents (e.g., training governance SOPs, training requirement standards and acceptance/qualification criteria), ensuring alignment with Patient Safety leadership and relevant Subject Matter Experts (SMEs).
  • Lead strategy discussions and serve as a key decision maker for vendor training priorities, training methodology, escalation paths and risk-based training approaches.
  • Ability to perform all responsibilities of more junior staff, including but not limited to:
  • Maintain high state of knowledge of the Safety database systems and reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and Good Clinical Practice (GCP) to ensure adherence/compliance.
  • In collaboration with Patient Safety Management, re-training Patient Safety employees on specific training objectives and providing feedback as needed.
  • Develop and maintain quality checkpoints to track and evaluate Patient Safety staff training and development progress and provide assessment feedback to employees and manager(s) as needed.
  • Develop and lead internal and external training related to safety.
  • Identify training and learning gaps (i.e. areas for improvement), make recommendations and lead implementation of training solutions for internal and external safety staff and suppliers in alignment with Patient Safety leadership and input from functional area Subject Matter Experts.
  • Support development and maintenance of Patient Safety eLearning modules on the Learning Management System (LMS).
  • Lead continuous improvement projects as required.
  • Assist Manager(s) with communication of safety information to others.
  • Add operational efficiencies through AI and automation solutions to support compliance reporting.
• Process & Documentation
  • Serve as subject matter expert (SME) on Safety database systems and reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and Good Clinical Practice (GCP) to ensure adherence/compliance. Translate regulatory and SOP requirements into training, guidance and operational best practices.
  • Ensure training governance documentation (including vendor training procedures and records) is controlled, versioned, and audit-ready.
  • Maintains up to date knowledge of the regulations and guidelines issued by FDA, Health Canada and ICH as well as other industry sources of information concerning current standards for safety and FDA reportability.
  • Review training-related deviations and CAPAs; supports the implementation of corrective actions impacting patient safety training to ensure deviations are corrected and closed in a timely manner.
  • Support inspection readiness by ensuring training records, SOP updates and evidence of competency are inspection-ready.
  • Work with internal stakeholders and subject matter experts to plan and implement automated solutions to improve daily operations with metric tracking.
• Project / Continuous Improvement
  • Identify areas for automation and improvement across GxP Compliance & Patient Safety training processes to include vendor oversight management, project trackers, mailbox management, metrics and KPIs.
  • Implement new technologies and systems to support employee onboarding and continuous learning initiatives.
  • Identify and evaluate tools and technology to streamline and simplify processes and lead implementations where needed.

Physical Requirements

This position can be based anywhere in the United States (remotely-based). Approximately 10% overnight travel.

Qualifications

• A Bachelor's Degree in Nursing or Pharmacy or medical or science related discipline required; relevant experience may be substituted for degree
• Experience in Pharmacovigilance training or mentorship is preferred
• Knowledge of medical terminology
• Excellent presentation, interpersonal, and stakeholder management and coaching skills, demonstrated ability to influence cross-functional stakeholders and lead training initiatives.
• GxP compliance training and oversight reporting
• High proficiency in PowerPoint, Word, Outlook and Excel
• Automation and artificial intelligence tools
• Creative and experienced in content creation
• Strong project management skills with abilities to manage multiple projects

The base compensation range for this position is $120,000 to $180,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

The job posting is anticipated to close on August 19th, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-us/careers.com.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy and parental leave policy.