What are the responsibilities and job description for the Director, Patient Safety Case Management position at BioSpace?
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 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?
The Position
Responsible for overseeing the end-to-end processes and resourcing for case processing. This role leads the Case Management Activities and oversight of case Intake, Triage and case processing. The role also involves oversight of Vendors and management of ICSR Verification teams, ensuring efficient operations for case processing and assessment. Serves as expert regarding case processing issues and 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.
Relationships
Reports to the Head of NNI Patient Safety, with cross-functional working relationships within Intake and Triage, Medical Review, Submissions and Compliance, Global Safety, and centralized teams (e.g., Training and Documentation, Quality, Supplier and Contract Management and Digital Enablement). This role will provide direct guidance to senior managers and managers involved in case triage, case processing and case verification. Works with Vendor leadership and hub leadership teams. Works closely patient safety leadership team members in Data Acquisition, Medical Review, and other case management leadership team members. 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.
Essential Functions
Leadership & Oversight
Lead and manage the global 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
Design, implement, and continuously improve procedures for AE/SAE case processing, including data collection, assignment, coding (drug/event), narrative development, and case assessment
Ensure alignment with evolving regulatory requirements and industry best practices
Global Coordination
Oversee communication and workflow integration across case processing hubs (U.S., Mexico City, Bangalore) and external vendors/contractors
Ensure seamless operations and timely delivery of safety data
Risk Management
Act as the primary point of escalation 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
Audit & Inspection Readiness
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
Physical Requirements: 0-10% travel required.
Development of People
Supervisory. 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
A bachelor’s degree required. An advanced degree is preferred (M.S., Pharm. D., Ph.D., M.D.)
At least 10 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
The base compensation range for this position is $181,670 to $317,920. 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's 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, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
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?
The Position
Responsible for overseeing the end-to-end processes and resourcing for case processing. This role leads the Case Management Activities and oversight of case Intake, Triage and case processing. The role also involves oversight of Vendors and management of ICSR Verification teams, ensuring efficient operations for case processing and assessment. Serves as expert regarding case processing issues and 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.
Relationships
Reports to the Head of NNI Patient Safety, with cross-functional working relationships within Intake and Triage, Medical Review, Submissions and Compliance, Global Safety, and centralized teams (e.g., Training and Documentation, Quality, Supplier and Contract Management and Digital Enablement). This role will provide direct guidance to senior managers and managers involved in case triage, case processing and case verification. Works with Vendor leadership and hub leadership teams. Works closely patient safety leadership team members in Data Acquisition, Medical Review, and other case management leadership team members. 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.
Essential Functions
Leadership & Oversight
Lead and manage the global 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
Design, implement, and continuously improve procedures for AE/SAE case processing, including data collection, assignment, coding (drug/event), narrative development, and case assessment
Ensure alignment with evolving regulatory requirements and industry best practices
Global Coordination
Oversee communication and workflow integration across case processing hubs (U.S., Mexico City, Bangalore) and external vendors/contractors
Ensure seamless operations and timely delivery of safety data
Risk Management
Act as the primary point of escalation 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
Audit & Inspection Readiness
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
Physical Requirements: 0-10% travel required.
Development of People
Supervisory. 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
A bachelor’s degree required. An advanced degree is preferred (M.S., Pharm. D., Ph.D., M.D.)
At least 10 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
The base compensation range for this position is $181,670 to $317,920. 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's 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, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
Salary : $181,670 - $317,920