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Director - Product Safety - Case Management

Company: Novo Nordisk A/S
Location: Plainsboro
Posted on: April 8, 2021

Job Description:

Set up notification on new jobs matching this search every days Create Alert Director - Product Safety - Case Management Facility: Clinical Development and Medical Location: Plainsboro, NJ, US About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-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? The Position Oversees the processes and resourcing for case intake, prioritization, coding and evaluation of all technical complaints and adverse events reported to Novo Nordisk Inc (NNI) Product Safety for marketed products. Serves as the lead of the Case Processing Group. Provides support and escalation channels for Product Safety (PS) intake, phone inquiries from patients and healthcare professions and case processing issues. Serves as an expert regarding case processing issues and required documentation and investigation of product complaints. Serves as the key contact person between NNI Product Safety and other departments for product complaint issues. Key contributor to NNI Product Safety innovation projects related to case processing activities. Relationships Reports to the Senior Director, Product Safety with cross-functional working relationships within Medical, Regulatory, Marketing, Quality Assurance (QA), Legal and IT. This person will provide direct guidance to a team of Associate Managers, intake and indirectly to all case processing specialists and associates. This position works closely with counterparts in the Global Safety (GS) Departments, including Safety Operations, IT & Quality and Customer Complaint Center. External relationships include interactions with patients, health care professionals. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department objectives. Essential Functions

  • Serves as a delegate for Senior Director for collaboration with Document Management team and Regulatory Affairs to ensure proper maintenance, retention and archiving of all Product Safety records
  • Serves as support to the management team for collaboration with GXP Support and Global Safety to develop training standards on adverse event data collection and reporting for the appropriate NNI staff
  • Develops, maintains and continuously optimizes common processes for adverse event data collection and delivery, reconciliation, drug and event coding, adverse event reporting and Technical complaints
  • Resource planning in collaboration with Global Safety (GS)--in HQ and Global Business Support
  • Collaborates with NNI PS Management and leads employees involved in the processing and evaluation of adverse event cases and ensures that adverse event information is processed according to corporate timelines and quality standards
  • Coaching partner for all direct and indirect reports, including others in PS Management Team
  • Oversees projects handled by the Continuous Improvement Group in PS
  • Provides expert assistance to colleagues in other departments in relation to safety activities
  • Serves as the Lead of the Case Processing Team and Product Safety Management Team
  • Applies knowledge of industry regulations and practices regarding product safety to follow the North American Regulatory requirements and Standard Operating Procedures (SOPs) and practices regarding Adverse Event processing and reporting
  • Maintains up to date knowledge of the regulations and guidelines issued by Food & Drug Administration (FDA) and International Conference on Harmonisation (ICH) as well as other industry sources of information concerning current standards for safety and FDA reportability
  • Serve as the back-up Pharmacovigilance responsible person for NNI
  • Ensures high quality medical and technical product information to health care professionals and patients relating to product safety
  • Oversees investigations into adverse drug and device reports with Novo Nordisk products with respect to applicable Federal regulations (Investigational New Drug (IND), New drug application (NDA), Medical Device Reporting (MDR), Good Manufacturing Practice (GMP)--and internal SOPs
  • Oversees the intake, triage and case processing of adverse medical events and malfunction reports with respect to FDA reportability (ie. 7-day, 15 day, MDR) Development of People Ensure that reporting personnel have individual development plans (IDP), 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 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. Qualifications
    • A Bachelor's degree required. An advanced degree is preferred (M.S., Pharm.D., Ph.D., M.D.)
    • At least twelve years of experience is required, related to Scientific, Regulatory, Pharmaceutical and Medical areas, with at least five years of experience in the product safety area
    • Supervisory management experience of at least five years is required
    • Good communication skills and organization skills are required
    • System knowledge of safety databases is mandatory 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. 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.

Keywords: Novo Nordisk A/S, Trenton , Director - Product Safety - Case Management, Executive , Plainsboro, New Jersey

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