Director - Patient Safety Data Acquisition

Director - Patient Safety Data Acquisition

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?

Responsible for overseeing and ensuring efficient operations for the Patient Safety Call Center, Intake and Triage, Customer Care Call Center, Product Quality / Technical Complaints, Patient Safety Organization Call Center Vendor. Provides support and escalation channels for both internal teams and external stakeholders, including patients and healthcare professionals, with inquiries, case handling issues, and process improvements related to patient safety. Also support case management activities within US Patient Safety Team.

Reports to the Head of NNI Patient Safety, with cross-functional working relationships within Case Processing, Medical Review, Submissions and Compliance and the centralized teams (e.g., Training and Documentation, Quality, Supplier and Contract Management and Digital Enablement). The Director Patient Safety Data Acquisition will provide strategic and operational leadership to the Patient Safety Call Center teams, Technical Complaints teams, and Customer Care Call Center teams. The Director Patient Safety Data Acquisition has direct and indirect oversight of key roles including the Intake manager(s), Triage manager(s), Technical Complaints Manager (s), various call handlers and external vendors supporting patient safety, customer care and technical complaints. This role also encompasses indirect management of call center agents. External relationships include interactions with patients and healthcare professionals. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department objectives.

The Director Patient Safety Data Acquisition is strategic leader responsible for overseeing the intake and initial triage of all safety information including adverse events, product complaints, and other safety concerns across various channels.

This person will lead cross-functional teams including Patient Safety Call Center teams, Technical Complaints teams, Customer Care Call Center teams and case management teams.

Collaborate with multiple internal and external stakeholders to optimize intake workflows, enhance data quality, and drive continuous improvement.

Develop, maintain, and continuously optimize procedures and processes for call center operations, non-call center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance.

Lead efforts to optimize call center workflows, implement training and performance metrics, manage vendor relationships, and ensure that frontline teams are equipped to capture and escalate safety information accurately and efficiently.

Collaborate with patient safety leadership in managing case management activities within safety databases and other supporting systems. Collaborate with NNI Patient Safety Management to ensure safety information is processed according to corporate timelines, quality and regulatory requirements.

Leads the safety follow-up process with consumers, healthcare professionals, and external vendors to proactively obtain critical case information, ensuring completeness and accuracy for timely processing and ongoing benefit-risk evaluation of Novo Nordisk products.

Monitor internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met.

Lead deviation management activities, including root cause analysis and implementation of CAPAs, to mitigate risk and strengthen safety operations.

Support the preparation of SDEAs, PVA and other contract documents in collaboration with other cross functional teams within Strategic Operations.

Forecasts and plans resource requirements for case intake across all channels, ensuring optimal staffing and operational readiness to support timely and compliant safety case processing.

Support inspection readiness by preparing documentation and participating in internal and external inspections.

Serve as the escalation point for safety-related risks, ensuring timely and effective resolution in coordination with relevant stakeholders.

Approximately 0-10% Travel might be required.

Supervisory. Verbiage below applies only to Supervisory roles; it is removed for individual contributors - DO NOT EDIT.

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.

A bachelor's degree required (in medical or science-related discipline) or relevant experience may be substituted for degree, when appropriate.

At least 8 years of experience is required, related to Scientific, Regulatory, Pharmaceutical and Medical areas, with at least 5-8 years of experience in pharmacovigilance.

Supervisory management experience of at least five years is preferred.

SME knowledge of global regulations including FDA and ICH regulations and guidelines.

Expertise in safety databases, call center telephony systems 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.