Director, Patient Safety Medical Review

Role Summary

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.

Responsibilities

• 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‚Äô 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 & Inspection Readiness
  • Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH as well as other industry sources of information concerning current standards for safety surveillance and FDA reportability
  • Support the preparation and execution of internal and external audits and regulatory inspections
  • Ensure documentation and processes are audit-ready and aligned with global pharmacovigilance standards

Qualifications

• MD or equivalent degree required
• At least 10 years of experience is required, related to Scientific, Regulatory, Pharmaceutical and Medical areas, with at least 6-8 years of experience in pharmacovigilance
• Supervisory management experience & Leading Therapeutic Areas and teams preferred
• SME knowledge of global regulations including FDA and ICH regulations and guideline
• Expertise in safety databases and quality systems
• Knowledge of NNI supported disease states preferred (e.g., diabetes, obesity, hemophilia, growth hormone disorders)
• Good communication skills and organizational skills are required
• Expertise in Workflow, Budgeting and KPI monitoring

Skills

• Leadership and people management
• Pharmacovigilance processes and regulatory compliance
• Safety data review and case processing
• Cross-functional collaboration
• Quality assurance and audit readiness

Education

• MD or equivalent degree required