US-NJ, Senior Director- Product Safety Job 440006800A2-MZ
|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 & 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 & Drug Administration, Adverse Event (AE), and Medical Device Reporting (MDR)) and relevant vendors. Internal stakeholders: Global Safety, Global Development, Product Supply
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 Policies: Tracks progress of Novo Nordisk Inc. quality issues and report it on a periodic basis. Leadership: Motivates the team to ensure high-quality delivery against targets. Maintenance of up-to-date Regulatory Guidelines: Attends FDA and industry meetings for safety issues as assigned. Maintains up-to-date knowledge of the regulations and guidelines issued by the FDA along with other industry periodicals impacting safety reporting issues. Miscellaneous: Handles other duties and/or special projects as assigned by the Vice President and the Senior Vice President. Participates in project team meetings as needed. Member of Global Safety Committee (GSCOMMAN). Other areas of responsibilities: Member of Global Safety Corrective and Preventative Action (CAPA) Forum according to QBIQ Doc. 181502.
10-20% overnight travel required.
Development of People
Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the Individual Development Plan (IDP) forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
* Bachelor’s degree required, advanced degree preferred (M.S., Pharm.D., Ph.D., M.D.)
* A minimum of 13 years’ increasing experience in area of specialty; a minimum of 6 years’ experience related to pharmaceutical safety reporting
* At least 3 years’ experience as manager of other people managers
* A very high degree of independent decision making is required on a daily basis for issues related to prioritizations and delegation of tasks and responsibilities in order to ensure regulatory compliance and to establish the Product Safety department in alignment with global directive
* International experience, preferably dealing with European authorities, HQ or affiliates ideally required
* Proven track record in collaborating with other business areas
* Proven track record of effective strategic planning, execution and follow-up
* Solid understanding of industry standards
* Ability to communicate with all levels of management
* Highly flexible, diplomatic skills, ability to work in global and culturally diverse environments preferred
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Department CMR - PRODUCT SAFETY (2)
Position Location US - Plainsboro, NJ
State/Provinces US - NJ
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Please visit our website at www.novonordisk.com