Executive Director - Patient Safety Case Management

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 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
Executive Director, Patient Safety Case Management is responsible person for USO Patient Safety Case Management, this position will serve as a key Patient Safety Subject Matter Expert (SME) and will work to establish, oversee and maintain processes, procedures and controls associated with Adverse Event (AE) and Technical Complaint (TC) reporting from intake through regulatory submission. The incumbent will collaborate closely with all transversal functions to ensure adherence to regulatory requirements and compliance standards across the organization. This role is responsible for the oversight of employees/activities performed at Global Business Support (GBS) hubs located in Mexico City, Mexico and Bangalore, India.
Overall responsible for activities related to the maintenance of the safety profile of the company's products (e.g. Local Labelling Committee, Promotional Review Board) in close collaboration with Headquarters (HQ).
The incumbent will also be accountable for ensuring appropriate resourcing and budgetary needs are met to support business objectives. Additionally, this role plays a critical part in strategic planning and execution to drive operational excellence and long-term success.
Additionally, this position will serve as a key contact person for all health governing body (i.e. FDA) inspections and audits as well as key contact for all safety related communications with the authorities.
Relationships
This position reports directly to the Vice President, CMR Strategic Operations. External relationships include regulatory authorities: FDA and MDR and relevant 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.
  • Ensure accurate and timely documentation of case information.
  • Coordinate with relevant teams to streamline case management processes and enhance efficiency.
• Lead Case Management and Medical Review
  • Direct the management of safety cases, ensuring thorough medical review.
  • Implement strategies for efficient case prioritization and resolution.
  • Collaborate with medical experts to ensure comprehensive case evaluations.
• Oversee Submission and Regulatory Compliance
  • Ensure timely submission of safety cases to regulatory authorities in the US.
  • Maintain compliance with all relevant governmental regulations.
  • Facilitate communication with regulatory bodies to address submission queries.
• Focus on Post-Marketing Adverse Events
  • Develop strategies to monitor and manage post-marketing adverse events.
  • Ensure effective communication of safety information to stakeholders.
  • Lead initiatives to enhance post-marketing safety surveillance.
• Drive Strategic Business Development and International Collaborations
  • Formulate business strategies to enhance case management operations.
  • Establish and maintain partnerships with international stakeholders to advance safety initiatives
  • Lead negotiations and collaborations with external partners to drive global safety standards.
• Oversee Patient Safety Call Center
  • Provide oversight for the patient safety call center to ensure effective case intake and triage.
  • Develop protocols to enhance call center operations and patient safety outcomes.
  • Monitor call center performance to ensure alignment with safety and regulatory standards.
• Oversee US Affiliates and Global Business Unit Hubs
  • Provide oversight for US affiliates, including global business unit hubs located in India and Mexico City.
  • Ensure alignment of safety case management practices across all locations.
  • Coordinate with international teams to maintain consistent safety standards globally.
• Risk-Based Data Insights
  • Responsible for the creation of KPIs for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific matters.
  • Strategize and align with the key stakeholders in developing data collection/processing strategies and in generating outputs using suitable Pharmacovigilance database retrieval strategies.
  • Experience with safety data collection and interpretation originating from clinical trials and other sources.
• Strategic Oversight
  • Provides effective and timely safety updates to management on matters concerning safety promotional review, safety labelling committee input, safety data analysis and contract review and vendor management for vendors handling safety information.
• Leadership
  • Provides strong people management of the Patient Safety leadership team acrossUSO, GBS, and NNCI including teambuilding, motivating, empowering and developing people.
• Regulatory Landscape
  • Maintains up-to-date knowledge of the regulations and guidelines issued by the FDA and Health Canada along with other industry periodicals impacting safety reporting issues.
  • Attends PV industry meetings

Physical Requirements
10-20% overnight travel required
Development of People

• Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

• Graduate degree in health sciences or other relevant health-related field (e.g. MD, PhD, PharmD, NP, PA, pharmacy, or nursing degree) with 10+ years of relevant experience in drug safety/pharmacovigilance, or related fields required
• Minimum of 6 years of people management experience required, and experience in mentoring others
• Proven track records of strategic decision-making and leadership skills
• Experience with Signal Detection and Pharmacovigilance databases i.e. Argus, Cognos, Empirica, etc.
• Excellent communication skills with clear ability to impact and influence without authority
• Demonstrated ability to work in a matrix environment and to influence key stakeholders as it relates to innovative safety science and pharmacovigilance
• In-depth knowledge of North America (US, CA), EU drug safety regulations, CIOMS and ICH guidelines required
• Strong collaboration skills with enterprise mindset
• Exhibit strong problem-solving skills to address complex safety issues and regulatory compliance.
• Act as a thought leader within the Safety Pharmacovigilance domain and across the organization.
• Develop and execute long- and short-term business strategies with significant impact.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.