TrentonRecruiter Since 2001
the smart solution for Trenton jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Manufacturing Manager
Description: JOB DESCRIPTION br br Job : 35887 Title: Manufacturing Manager Job Location: New Brunswick, New Jersey - United States Employment Type: Salary: contact recruiter for details Employer Will Recruit (more...)
Company: NPAworldwide Recruitment Network
Location: New Brunswick
Posted on: 04/14/2021

Restaurant Manager
Description: Company Description br br At True Food Kitchen, we are purveyors of nourishment for the wellness-aware. We believe that living well isn't just about eating the right food, but about sharing it with (more...)
Company: True Food Kitchen
Location: Hackensack
Posted on: 04/14/2021

Salon Manager - Commerce Center
Description: Salon Manager Got shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: New Brunswick
Posted on: 04/14/2021


Relationship Manager
Description: If you thrive on creating strong, value-add business relationships while ensuring the best possible customer experience, we are looking for you. Through your skills in training, issue resolution, workflow (more...)
Company: First Source Title Agency, Inc
Location: Hoboken
Posted on: 04/14/2021

Consumer and Real Estate Lending Manager
Description: This website is AudioEye enabled and is being optimized for accessibility.
Company: Everence
Location: Lancaster
Posted on: 04/14/2021

Physician's Assistant/Nurse Practitioner - Pain Management
Description: At Lancaster General Health, our culture is what sets us apart and creates a lasting impression of our health system in the community and in the hearts of our patients and their families. A role with (more...)
Company: Lancaster General Health
Location: Lancaster
Posted on: 04/14/2021

Chief Financial Officer
Description: The CFO will work closely with the President and other members of the Board to develop and implement business strategy and deliver growth. In this role, the CFO will lead the accounting and finance teams, (more...)
Company: Halma plc
Location: White Plains
Posted on: 04/14/2021

Family Practice in PA - Associate Director for Core Faculty Team Needed in Pennsylvania
Description: Medical Director opening in Lancaster, Pennsylvania. This and other physician jobs brought to you by DocCafe.com CompHealth is assisting an osteopathic faculty team in Pennsylvania with their search for (more...)
Company: CompHealth
Location: Lancaster
Posted on: 04/14/2021

11B Infantryman - Management Training (Lancaster,PA)
Description: Job Description br br The Infantry is the backbone of the Army. These Soldiers fill the literal boots on the ground who are responsible for taking or holding ground during any combat operation. You'll (more...)
Company: Army National Guard
Location: Lancaster
Posted on: 04/14/2021

Supply Chain Manager
Description: Supply Chain Manager Pharmaceutical Manufacturing Industry Experience Princeton, New Jersey Are you looking to make a career change to a stable company This exciting opportunity offers a competitive (more...)
Company: Ajulia Executive Search
Location: New Brunswick
Posted on: 04/14/2021

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Trenton RSS job feeds