Senior Patient Safety Case Management Manager

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.

• 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/Aris Global) 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.

• 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