Senior Patient Safety Case Management Manager
Novo Nordisk
14 hours ago
Remote friendly (Plainsboro, NJ)
United States
Operations
Responsibilities:
- Ensure compliance with Federal regulations and company SOPs for safety reporting (post-marketing and clinical trials) for all NNI US marketed products (drugs/devices).
- Manage daily Patient Safety case processing: receipt, documentation, triage, case review, and quality assessment of serious/non-serious adverse events, technical complaints, and analysis results.
- Evaluate daily GxP lists for FDA submission of individual case safety reports.
- Assist with periodic/annual FDA reporting.
- Monitor deliverable quality and coach/feedback to case handlers; support triage, case classification/assignment, and workload coordination.
- Handle escalated case calls and investigate unique situations.
- Oversee Patient Support/Market Research programs, call centers, digital health monitoring, and registries (including contract review/negotiation and SDEA requirements).
- Support internal/external safety reporting training.
- Serve as Subject Matter Expert during audits/inspections and lead audit/inspection execution.
- Collaborate with Global Safety to align case-handling instructions; drive CAPA and deviation registration.
- Prepare monthly KPI and Time Limit Exceeding updates; support metrics and QMR reporting.
- Provide product information responses using approved labeling/call scripts; recommend and implement process improvements; lead system/project initiatives; develop/maintain local SOPs.
Qualifications:
- 8+ years pharmacovigilance experience (incl. MedDRA coding and AE reporting) required.
- Bachelor’s degree required (medical/life science); advanced degree preferred; RN substitution acceptable.
- Pharmacovigilance database experience (ARGUS/ArisGlobal) required.
- Exceptional medical/pharmacovigilance terminology knowledge; strong analytical thinking; audit/inspection experience.
- Proficiency in Windows and Microsoft Word/Excel/Outlook required.
- Strong communication, attention to detail, confidentiality, multitasking, planning/organization, and stakeholder relationship skills.
- Preferred: NNI disease state knowledge; call center or 2+ years customer service.
Benefits (explicitly stated): medical/dental/vision, life/disability, 401(k), flexible spending, employee assistance, tuition reimbursement, voluntary benefits (e.g., group legal/critical illness/identity theft/pet/auto-home insurance), sick/flexible vacation and parental leave.
Application instruction: For accommodation requests only, call 1-855-411-5290.
- Ensure compliance with Federal regulations and company SOPs for safety reporting (post-marketing and clinical trials) for all NNI US marketed products (drugs/devices).
- Manage daily Patient Safety case processing: receipt, documentation, triage, case review, and quality assessment of serious/non-serious adverse events, technical complaints, and analysis results.
- Evaluate daily GxP lists for FDA submission of individual case safety reports.
- Assist with periodic/annual FDA reporting.
- Monitor deliverable quality and coach/feedback to case handlers; support triage, case classification/assignment, and workload coordination.
- Handle escalated case calls and investigate unique situations.
- Oversee Patient Support/Market Research programs, call centers, digital health monitoring, and registries (including contract review/negotiation and SDEA requirements).
- Support internal/external safety reporting training.
- Serve as Subject Matter Expert during audits/inspections and lead audit/inspection execution.
- Collaborate with Global Safety to align case-handling instructions; drive CAPA and deviation registration.
- Prepare monthly KPI and Time Limit Exceeding updates; support metrics and QMR reporting.
- Provide product information responses using approved labeling/call scripts; recommend and implement process improvements; lead system/project initiatives; develop/maintain local SOPs.
Qualifications:
- 8+ years pharmacovigilance experience (incl. MedDRA coding and AE reporting) required.
- Bachelor’s degree required (medical/life science); advanced degree preferred; RN substitution acceptable.
- Pharmacovigilance database experience (ARGUS/ArisGlobal) required.
- Exceptional medical/pharmacovigilance terminology knowledge; strong analytical thinking; audit/inspection experience.
- Proficiency in Windows and Microsoft Word/Excel/Outlook required.
- Strong communication, attention to detail, confidentiality, multitasking, planning/organization, and stakeholder relationship skills.
- Preferred: NNI disease state knowledge; call center or 2+ years customer service.
Benefits (explicitly stated): medical/dental/vision, life/disability, 401(k), flexible spending, employee assistance, tuition reimbursement, voluntary benefits (e.g., group legal/critical illness/identity theft/pet/auto-home insurance), sick/flexible vacation and parental leave.
Application instruction: For accommodation requests only, call 1-855-411-5290.