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Posted: Thursday, February 8, 2018 12:24 PM

Requisition ID 51453BR
Title Senior Director: Product Safety
Job Category Clinical Development
Job Description Purpose
As Novo Nordisk Inc. responsible person for pharmacovigilance, establishes and maintains processes, procedures and controls to ensure and maintain compliance with all relevant internal and external requirements and regulations relating to technical complaints, adverse events and other safety information. Overall responsible for Novo Nordisk Inc. compliance with United States drug and device safety reporting regulations, International Council Harmonisation (ICH) guidelines and the management of contracts with safety reporting requirements across Novo Nordisk Inc. Key contact person for Food and Drug Administration (FDA) Pharmacovigilance (PV) inspections and device inspections as well as key contact for all safety related communications with FDA. Responsible for providing strategic vision, expertise, leadership and direction for Product Safety at Novo Nordisk Inc. as well as significantly contributing to the strategic vision of Clinical Medical Regulatory (CMR) Operations. Overall responsible for activities related to the maintenance of the safety profile of the company's products (e.g. Local Labeling Committee, Promotional Review Board) in close collaboration with Headquarters.
This position reports directly to the Vice President, CMR Operations and is accountable for managing multiple internal relationships within Novo Nordisk Inc. and Global Headquaters. Works with all departments and internal Novo Nordisk stakeholders to ensure adherence to United States regulations and company Standard Operating Procedures (SOPs) with respect to safety reporting internally, works in close collaboration with leadership across the organization,: including CMR, Marketing, Legal, Compliance, BioPharm, Commercial Effectiveness, and Human Resources. Works in close collaboration with Global Safety counterparts at Novo Nordisk affiliates and headquarters. External relationships include regulatory authorities (Food and Drug Administration, Adverse Event (AE), and Medical Device Reporting (MDR)) and relevant vendors. Internal stakeholders: Global Safety, Global Development, Product Supply
Essential Functions
Accountability: Ensures efficient processes to meet internal and external timelines. Designs and promotes systems to continuously improve business productivity within and across departments in relation to department and company goals and objectives. Assures that U.S. regulatory and strategic insights and inputs are provided to shape Global Safety strategic initiatives. Serves as an internal expert and key resource for safety related questions and concerns. Assurance of Compliance with FDA AE and MDR Safety Reporting Regulations: Directs the safety department activities to ensure FDA safety submissions as required. Participates on Novo Nordisk Inc.'s behalf regarding FDA safety reporting responsibilities. Establishment of Compliance with Standard Policies: Directs the development of SOPs at Novo Nordisk Inc. documenting compliance with corporate policies and local safety needs. Audits: Ensures coordination and oversight of internal PV audits and external PV inspections at Novo Nordisk Inc. (i.e. FDA or any other external healthcare related inspection). Product Quality: Oversees the implementation of procedures to ensure compliance with Good Manufacturing Practice (GMP) with respect to technical complaint handling at Novo Nordisk Inc.. Strategic Team Leadership/Planning: Provides expertise on Good Pharmacovigilance, Manufacturing, Distribution and Clinical practice compliance issues and actions. Strategic Oversight: Provides direction to function and Novo Nordisk Inc. management on matters concerning safety promotional review, safety labelling committee input, safety data analysis and contract review and vendor management for vendors handling safety information. Establishment of Compliance with Standard


• Location: Jersey Shore, plainsboro

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