Executive Director - Patient Safety Case Management
Location:
Plainsboro, United States
Job Category:
Clinical Development
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 health-care-provider interactions to developing and implementing regulatory strategies with the FDA, CMR is deeply involved in improving patient quality of life through cutting-edge medical and regulatory efforts.
The Position
The Executive Director of Patient Safety Case Management is responsible for overseeing the USO Patient Safety Case Management department. This leadership role entails managing processes, procedures, and controls associated with adverse event (AE) and technical complaint (TC) reporting, ensuring regulatory compliance, and collaborating with cross-functional teams. The incumbent will oversee teams in Mexico City and Bangalore and manage the overall safety profile of Novo Nordisk's products, working closely with key global stakeholders.
Relationships
Reports to: Vice President, CMR Strategic Operations
External Relationships: Regulatory authorities (FDA, MDR), vendors
Internal Stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (USO), marketing, legal, and USO Patient Support Solutions
Essential Functions
Manage Case Intake, Triage, and Processing:
Oversee the intake, triage, and processing of safety cases in compliance with US regulations.
Lead Case Management and Medical Review:
Direct case management, ensuring efficient prioritization, review, and resolution.
Submission and Regulatory Compliance:
Ensure accurate submission of safety cases to regulatory authorities and maintain compliance.
Post-Marketing Adverse Events:
Lead strategies to monitor and manage post-marketing adverse events and communicate findings.
Strategic Business Development:
Formulate business strategies to enhance operations and collaborate internationally to set global safety standards.
Oversee Patient Safety Call Center:
Provide oversight for call center operations to ensure timely and compliant case intake.
Oversight of US Affiliates and Global Business Units:
Ensure alignment of safety practices across locations in the US, India, and Mexico.
Risk-Based Data Insights:
Develop KPIs for regulatory reporting, safety evaluations, and product-specific data matters.
Strategic Oversight:
Deliver safety updates to management on product safety and regulatory compliance.
Leadership:
Provide people management for the Patient Safety leadership team, mentoring and motivating team members.
Qualifications
Education/Experience:
Graduate degree in health sciences (e.g., MD, PhD, PharmD, NP, PA) with 10+ years of relevant experience in drug safety/pharmacovigilance, including at least 6 years in people management.
Skills:
Proven track record of strategic decision-making and leadership
Experience with pharmacovigilance databases (e.g., Argus, Cognos, Empirica)
Strong collaboration and communication skills
Expertise in North American and EU drug safety regulations
Ability to address complex safety and regulatory issues
Physical Requirements
10-20% overnight travel required
Development of People
Ensure individual development plans (IDPs) are in place for all team members, promoting continuous growth aligned with business objectives.
Novo Nordisk Commitment
Novo Nordisk is an equal opportunity employer, valuing diverse perspectives and fostering an inclusive work environment for all employees. If special assistance is required to apply, please contact Novo Nordisk at 1-855-411-5290.
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