Senior Patient Safety Case Management Manager
Novo Nordisk
June 26, 2026
On-site
Plainsboro, NJ
Patient Advocacy
The Position
- Ensure compliance with Federal regulations and company SOPs for safety reporting from post-marketing and clinical trial sources for Novo Nordisk Inc. (NNI) US marketed products (drugs and devices).
- Support workflow management and coordination of daily Product Patient Safety case processing activities, including receipt, documentation, triage, case review, and quality assessment of inbound safety information (serious and non-serious adverse events) in local intake tools, complaint systems, and global safety databases.
- Support compliance reporting and quality tasks to ensure consistency and compliance.
- Evaluate daily GXP lists for FDA regulatory submission of individual case safety reports.
- Assist with preparation of periodic and annual FDA reports.
- Monitor deliverable quality; provide feedback to case handlers.
- Support triage, case classification/assignment, workflow allocation, and workload coordination.
- Handle escalated calls and investigate unique situations.
- Maintain oversight for Patient Support Programs/Market Research/call centers/digital health/social media monitoring/registries (including contract review/negotiation and SDEA requirements).
- Support training activities (internal/external).
- Serve as Subject Matter Expert during audits/inspections; lead audit/inspection process.
- Collaborate with Global Safety on aligned case handling instructions.
- Register deviations; participate in CAPA implementation.
- Direct root cause analysis and corrective/preventive actions for late reporting.
- Prepare monthly KPI monitoring reports and Time Limit Exceeding updates; support QMR reporting.
- Respond to product information inquiries using approved labeling/call scripts.
- Identify process improvements; lead projects (system upgrades/boosters/initiatives) and develop/maintain local SOPs.
Physical Requirements
- 0–10% overnight travel; may work holidays/weekends. Onsite in Plainsboro, NJ, 5 days/week.
Qualifications
- 8+ years progressively responsible, relevant pharmacovigilance experience (incl. MedDRA coding and adverse event reporting) required.
- Bachelor’s degree required (medical/life science); relevant experience may substitute (e.g., RN with 5+ years, including 3 years clinical care and/or safety reporting). Advanced degree preferred.
- Pharmacovigilance database experience (ARGUS, ArisGlobal) required.
- Exceptional knowledge of medical/pharmacovigilance terminology; strong analytical thinking.
- Audits/inspections experience required.
- Proficiency in Windows, Microsoft Word/Excel/Outlook required.
- Strong oral/written communication; attention to detail; confidentiality; ability to manage multiple priorities and fast-paced demands.
- Strong planning/organization/time management.
- Ability to interact across organizational levels and build stakeholder relationships.
Preferred
- Knowledge of NNI supported disease states (e.g., diabetes, obesity, hemophilia, growth hormone disorders).
- Call center or 2+ years customer service experience.
Application Instructions
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodation requests only).
- Ensure compliance with Federal regulations and company SOPs for safety reporting from post-marketing and clinical trial sources for Novo Nordisk Inc. (NNI) US marketed products (drugs and devices).
- Support workflow management and coordination of daily Product Patient Safety case processing activities, including receipt, documentation, triage, case review, and quality assessment of inbound safety information (serious and non-serious adverse events) in local intake tools, complaint systems, and global safety databases.
- Support compliance reporting and quality tasks to ensure consistency and compliance.
- Evaluate daily GXP lists for FDA regulatory submission of individual case safety reports.
- Assist with preparation of periodic and annual FDA reports.
- Monitor deliverable quality; provide feedback to case handlers.
- Support triage, case classification/assignment, workflow allocation, and workload coordination.
- Handle escalated calls and investigate unique situations.
- Maintain oversight for Patient Support Programs/Market Research/call centers/digital health/social media monitoring/registries (including contract review/negotiation and SDEA requirements).
- Support training activities (internal/external).
- Serve as Subject Matter Expert during audits/inspections; lead audit/inspection process.
- Collaborate with Global Safety on aligned case handling instructions.
- Register deviations; participate in CAPA implementation.
- Direct root cause analysis and corrective/preventive actions for late reporting.
- Prepare monthly KPI monitoring reports and Time Limit Exceeding updates; support QMR reporting.
- Respond to product information inquiries using approved labeling/call scripts.
- Identify process improvements; lead projects (system upgrades/boosters/initiatives) and develop/maintain local SOPs.
Physical Requirements
- 0–10% overnight travel; may work holidays/weekends. Onsite in Plainsboro, NJ, 5 days/week.
Qualifications
- 8+ years progressively responsible, relevant pharmacovigilance experience (incl. MedDRA coding and adverse event reporting) required.
- Bachelor’s degree required (medical/life science); relevant experience may substitute (e.g., RN with 5+ years, including 3 years clinical care and/or safety reporting). Advanced degree preferred.
- Pharmacovigilance database experience (ARGUS, ArisGlobal) required.
- Exceptional knowledge of medical/pharmacovigilance terminology; strong analytical thinking.
- Audits/inspections experience required.
- Proficiency in Windows, Microsoft Word/Excel/Outlook required.
- Strong oral/written communication; attention to detail; confidentiality; ability to manage multiple priorities and fast-paced demands.
- Strong planning/organization/time management.
- Ability to interact across organizational levels and build stakeholder relationships.
Preferred
- Knowledge of NNI supported disease states (e.g., diabetes, obesity, hemophilia, growth hormone disorders).
- Call center or 2+ years customer service experience.
Application Instructions
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodation requests only).