Novo Nordisk Group
Director - Patient Safety Data Acquisition
Novo Nordisk Group, Trenton, New Jersey, United States
The Position
Location Plainsboro, United States Job category Reg Affairs & Safety Pharmacovigilance 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? About the Department
The Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk focuses on patient safety, data integrity, and regulatory strategies to support product development and lifecycle management. Relationship
Reports to
The Head of NNI Patient Safety. The Director will work with Case Processing, Medical Review, Submissions and Compliance and centralized teams (e.g., Training and Documentation, Quality, Supplier and Contract Management, Digital Enablement). The Director Patient Safety Data Acquisition provides strategic and operational leadership to the Patient Safety Call Center teams, Technical Complaints teams, and Customer Care Call Center teams. The Director has direct and indirect oversight of Intake managers, Triage managers, Technical Complaints Managers, various call handlers and external vendors, and indirect management of call center agents. External relationships include interactions with patients and healthcare professionals. The role promotes and develops initiatives to improve working relationships across departments in relation to department objectives. Essential Functions
The Director Patient Safety Data Acquisition is a 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 Leads cross-functional teams including Patient Safety Call Center teams, Technical Complaints teams, Customer Care Call Center teams and case management teams Collaborates with multiple internal and external stakeholders to optimize intake workflows, enhance data quality, and drive continuous improvement Develops, maintains, and continuously optimizes procedures and processes for call center operations, non-call center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance Leads 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 Collaborates with patient safety leadership in managing case management activities within safety databases and other supporting systems; collaborates 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 Monitors internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Leads deviation management activities, including root cause analysis and implementation of CAPAs to mitigate risk and strengthen safety operations Supports the preparation of SDEAs, PVAs and other contract documents in collaboration with 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 Supports inspection readiness by preparing documentation and participating in internal and external inspections Serves as the escalation point for safety-related risks, ensuring timely and effective resolution in coordination with relevant stakeholders Physical Requirements
Approximately 0-10% travel may be required. Development of People
Supervisory roles. Ensure reporting personnel have individual development plans (IDP) with annual goals and measurements aligned to business priorities, interim reviews, and accountability. Manage policies and Novo Nordisk Way communication, and ensure IDP forms include learning and aspiration plans for all reporting personnel to enable goal achievement and increased responsibility. Qualifications
A bachelor’s degree is required (in medical or science-related discipline) or relevant experience may be substituted for degree, when appropriate At least 8 years of experience in Scientific, Regulatory, Pharmaceutical and Medical areas, with 5-8 years in pharmacovigilance Supervisory management experience of at least five years is preferred Subject matter expert 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 and organizational skills Expertise in Workflow, Budgeting and KPI monitoring The base compensation range for this position is $240,000 to $280,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and/or company vehicles depending on the position level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flexible vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. 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.
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Location Plainsboro, United States Job category Reg Affairs & Safety Pharmacovigilance 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? About the Department
The Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk focuses on patient safety, data integrity, and regulatory strategies to support product development and lifecycle management. Relationship
Reports to
The Head of NNI Patient Safety. The Director will work with Case Processing, Medical Review, Submissions and Compliance and centralized teams (e.g., Training and Documentation, Quality, Supplier and Contract Management, Digital Enablement). The Director Patient Safety Data Acquisition provides strategic and operational leadership to the Patient Safety Call Center teams, Technical Complaints teams, and Customer Care Call Center teams. The Director has direct and indirect oversight of Intake managers, Triage managers, Technical Complaints Managers, various call handlers and external vendors, and indirect management of call center agents. External relationships include interactions with patients and healthcare professionals. The role promotes and develops initiatives to improve working relationships across departments in relation to department objectives. Essential Functions
The Director Patient Safety Data Acquisition is a 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 Leads cross-functional teams including Patient Safety Call Center teams, Technical Complaints teams, Customer Care Call Center teams and case management teams Collaborates with multiple internal and external stakeholders to optimize intake workflows, enhance data quality, and drive continuous improvement Develops, maintains, and continuously optimizes procedures and processes for call center operations, non-call center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance Leads 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 Collaborates with patient safety leadership in managing case management activities within safety databases and other supporting systems; collaborates 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 Monitors internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Leads deviation management activities, including root cause analysis and implementation of CAPAs to mitigate risk and strengthen safety operations Supports the preparation of SDEAs, PVAs and other contract documents in collaboration with 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 Supports inspection readiness by preparing documentation and participating in internal and external inspections Serves as the escalation point for safety-related risks, ensuring timely and effective resolution in coordination with relevant stakeholders Physical Requirements
Approximately 0-10% travel may be required. Development of People
Supervisory roles. Ensure reporting personnel have individual development plans (IDP) with annual goals and measurements aligned to business priorities, interim reviews, and accountability. Manage policies and Novo Nordisk Way communication, and ensure IDP forms include learning and aspiration plans for all reporting personnel to enable goal achievement and increased responsibility. Qualifications
A bachelor’s degree is required (in medical or science-related discipline) or relevant experience may be substituted for degree, when appropriate At least 8 years of experience in Scientific, Regulatory, Pharmaceutical and Medical areas, with 5-8 years in pharmacovigilance Supervisory management experience of at least five years is preferred Subject matter expert 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 and organizational skills Expertise in Workflow, Budgeting and KPI monitoring The base compensation range for this position is $240,000 to $280,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and/or company vehicles depending on the position level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flexible vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. 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.
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