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Specialist - Patient Safety Data Acquisition And Support

3+ years
$81,010 – $145,820
10 Nov. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Specialist – Patient Safety Data Acquisition & Support

Location: Plainsboro, United States
Category: Regulatory Affairs & Safety / Pharmacovigilance
Company: Novo Nordisk
Employment Type: Full-Time


About the Department

The Clinical, Medical and Regulatory (CMR) department is one of Novo Nordisk’s most collaborative and diverse divisions. Responsibilities range across:

  • Healthcare provider engagement

  • FDA regulatory strategy

  • Medical education

  • Data collection for efficacy and product development

CMR works with a patient-first mindset, continuously innovating to improve health outcomes worldwide.


Position Summary

The Specialist manages day-to-day operations of the Patient Safety & Technical Complaints Contact Center, ensuring smooth functioning, compliance, and continuous improvement. The role supports operational excellence, vendor oversight, safety data capture, and the overall patient experience.

The role requires someone who can work independently, cross-functionally, and with strong operational ownership.


Reporting & Key Relationships

Reports to:

  • Director, Patient Safety Data Acquisition and Support

Internal interactions:

  • Patient Safety

  • Patient Support Programs

  • Commercial Operations

  • Commercial

  • NNI IT & Telephony

  • Medical Information

  • Product Safety

  • Regulatory

  • Quality

  • Legal

  • Privacy

  • Finance

External interactions:

  • Customer Care vendor

  • Patient support program vendors

  • Marketing agencies

  • Professional service vendors


Essential Functions

1. Operational Management & Business Support

  • Lead daily operations of the Patient Safety & Technical Complaints Contact Center

  • Support all current and future launch products across the NNI portfolio

  • Oversee intake of adverse events, product technical complaints, and safety data

  • Ensure full compliance with Novo Nordisk and FDA requirements

  • Create and manage vendor call scripts; coordinate Promotional Review Board approvals

  • Optimize communication channels (email, phone, fax, SMS) for patient support

  • Champion technological advancements for patient support systems and channels

  • Manage follow-up activities for collection of key patient safety data

  • Oversee Source Data Verification of calls and other intake channels

  • Ensure all vendor partners complete required training; maintain documentation and compliance

  • Development and management of training materials for vendor teams


2. Program Compliance

  • Implement process improvements and program changes to maintain compliance and excellence

  • Conduct call quality calibrations; provide feedback and guidance

  • Train vendor teams on updated processes and documentation standards

  • Create and interpret performance dashboards to monitor KPIs, trends, and opportunities

  • Manage vendor performance to contractual expectations, SOPs, and budgets


Physical Requirements

  • 0–10% travel


Qualifications

Education

  • Bachelor’s degree required

  • Preferred: Health Sciences background (Pharmacy, Nursing, etc.)

Experience

  • Minimum 3+ years in patient safety, case management, market access, or similar roles

  • Pharmaceutical or healthcare experience preferred

Technical & Professional Skills

  • Experience with:

    • CRM systems

    • Safety databases

    • Telephony platforms

  • Strong understanding of pharmaceutical environment (legal, medical, regulatory, clinical)

  • Strong analytical, problem-solving, and decision-making skills

  • Excellent project management skills; experience managing multiple priorities

  • Strong vendor management and ability to hold teams accountable

  • Proficiency in MS Word, PowerPoint, Excel

  • Strong customer service orientation


Compensation & Benefits

Base Salary Range

$81,010 – $145,820
(based on experience and role factors)

Additional Compensation

  • Company performance bonus

  • Long-term incentives

  • Company vehicle (role-dependent)

Benefits

  • Medical, dental, vision insurance

  • Life and disability coverage

  • 401(k) savings plan

  • Flexible spending accounts

  • Employee assistance program

  • Tuition reimbursement

  • Legal, critical illness, identity theft, pet, auto/home insurance

  • Sick time, flexible vacation policy, parental leave


Diversity, Inclusion & Accessibility

Novo Nordisk is an equal opportunity employer, committed to fair hiring practices, regardless of:

  • Race

  • Ethnicity

  • Color

  • Religion

  • Sex

  • Gender identity

  • Sexual orientation

  • National origin

  • Disability

  • Veteran status

  • Or any protected characteristic

Special accommodation requests:
📞 1-855-411-5290 (for ADA accommodations only)