Director - Patient Safety Data Acquisition

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Director - Patient Safety Data Acquisition Join to apply for the Director - Patient Safety Data Acquisition role at BioSpace 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? About The Position The Director Patient Safety Data Acquisition is responsible for overseeing and ensuring efficient operations for the Patient Safety Call Center, Intake and Triage, Customer Care Call Center, Product Quality/Technical Complaints, Patient Safety Organization Call Center Vendor. 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. Relationship Reports to the Head of NNI Patient Safety, with cross-functional working relationships within Case Processing, Medical Review, Submissions and Compliance and the centralized teams (e.g., Training and Documentation, Quality, Supplier and Contract Management and Digital Enablement). Essential Functions
Strategic leader responsible for overseeing the intake and initial triage of all safety information including adverse events, product complaints, and other safety concerns across various channels Lead cross-functional teams including Patient Safety Call Center teams, Technical Complaints teams, Customer Care Call Center teams and case management teams Collaborate with multiple internal and external stakeholders to optimize intake workflows, enhance data quality, and drive continuous improvement Develop, maintain, and continuously optimize procedures and processes for call center operations, non-call center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance Qualifications
A bachelor’s degree required (in medical or science-related discipline) or relevant experience may be substituted for degree, when appropriate At least 8 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 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.
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Location:
Plainsboro, NJ, United States
Job Type:
FullTime
Category:
Bio & Pharmacology & Health

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