Director, Patient Safety Medical Review

About the Department

 

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

 

 

The Position

The Director Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of Individual Case Safety Reports and other safety reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor on Patient Safety Operations including handling of all safety case processing activities for adverse events (AEs) and associated product quality complaints (PQC) for US Operations (USO) post-marketed products from all the sources. The Director is responsible for mentoring coaching and meeting the compliance requirements for the Medical Review Team.

 

Relationship

Reports directly to Head of PV Case Management. This role involves the oversight of case handling activities across the locations. Collaborate with the other departments within Patient Safety organization, CMR, outside of CMR, and Global Patient Safety and Safety Surveillance teams. Works closely with Promotional Review Board as required.

 

Essential Functions

• Leadership & Oversight
  • Lead and manage the Medical Review Case Processing team, fostering a culture of accountability, collaboration, and continuous improvement
  • Provide expert guidance to cross-functional teams regarding safety case management activities
• Process Development & Optimization
  • Oversees medical review of individual case safety reports for medical content, evaluation of expectedness/listedness and assessment of regulatory status for expedited reporting Design, implement, and continuously improve procedures for AE/SAE case processing from all sources including solicited and unsolicited reports
  • Provide Medical Review Strategy and advise for various case processing activities such as data acquisition, collection, seriousness and coding (drug/event), narrative development, and case assessment
  • Ensure alignment with evolving regulatory requirements and industry best practices. Manage the processing and submission of safety reports including ICSR electronic submissions, IND safety reports and Medical Device Reports, and aggregate reports

• Local Labelling Committee and Promotional Review Board Advisory
  • Oversees Patient Safety input to all products’ Local Labeling Committees
  • Responsible for ensuring active Patient Safety participation in PRB meetings for all NN products
  • Participate is Suspect Product Committee as delegated
• Global Coordination
  • Oversees local PSUR and DSUR activities for all products, in collaboration with Managers in Patient Safety and Global teams
  • Oversee communication and workflow integration across case processing hubs (U.S., Mexico City, Bangalore & vendors) and external vendors/contractors
  • Ensure seamless operations and timely delivery of safety data

• Risk Management
  • Act as the primary point of escalation for Medical Assessment, Provide Medical Advice and Strategy for case-related risks and operational challenges
  • Collaborate with internal stakeholders to proactively identify and mitigate potential issues
• Compliance & Quality Assurance
  • Partner with NNI Patient Safety Management to ensure timely and accurate processing of safety information in accordance with corporate standards
  • Monitor internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met
  • Implement Medical Review Prospective & Retrospective Quality Review of cases

• Regulatory Intel & Inspe