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

Coordinates and Oversees Patient Safety (PS) employees' onboarding and on-the-job training for pharmacovigilance as well as Safety training conducted for internal and external stakeholders. Coordinates project activities and needs related to Patient Safety. Ensures compliance with Federal regulations and company SOPs regarding collection, verification, and maintenance of adverse events (AE), device incidents, technical complaints, and other safety information for all Novo Nordisk products.

Relationships

Reports to Associate Director, Patient Safety Training. Internal relationships include all Patient Safety personnel. Other relationships include interaction with necessary parties at all levels of the business with regards to Patient Safety training. External relationships include interaction with vendors and other supplier to Safety.

Essential Functions

• Training:

• Maintain high state of knowledge of the Safety database systems and reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and Good Clinical Practice (GCP) to ensure adherence/compliance

• Plan, oversee, coordinate , conduct and document all Safety new hire training programs, including local and global trainings, onboarding and mentorship plans

• conduct training on safety case processing, work instructions, and use of database systems and reporting tools to Patient Safety employees (new and incumbent) including Safety incumbent update programs

• Maintain functional knowledge of all case processing conventions and nuances to deliver training effectively

• In collaboration with Patient Safety Management re- training to Patient Safety employees on specific training objectives and provide feedback as needed

• Develop and maintain new-hired introduction training programs for new Patient Safety employees. Document training and issue training record for new employees

• Develop, maintain, and deliver training material on safety related matters including SOPs and FDA guidelines on timely collection and reporting of safety information to relevant internal stakeholders e.g. external PV stakeholders e.g. vendor(s)

• Develop and maintain functional proficiency in the areas of staff case processing (e.g Triage, event coding, case processing, product use and disease state knowledge)

• Develop and maintain quality check-points to track and evaluate employee’s training progress and provide assessment feedback to employees and manager(s) as needed

• Coordinate internal and external trainings related to safety

• Identify areas for improvement with input from functional area Subject Matter Experts and make recommendations for training to internal and external safety staff and suppliers

• Support development and maintenance of Patient Safety eLearning modules on the Learning Management System (LMS)

• Call monitoring of Patient Safety calls as it relates to training progression

• Participate in continuous improvement projects as required

• Assist Manager(s) with communication of safety information to others

• Process & Documentation:

• Serves as subject matter expert (SME) on Safety database systems and reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and Good Clinical Practice (GCP) to ensure adherence/compliance

• Updates NAO Patient Safety SOPs and necessary guidance/training documents to ensure adherence/compliance as needed

• Maintains up to date knowledge of the regulations and guidelines issued by FDA, Health Canada and ICH as well as other industry sources of information concerning current standards for safety and FDA reportability

  Physical Requirements

  0-10% overnight travel required.

  Qualifications

• A Bachelor’s degree in Nursing or Pharmacy or Health Science required; relevant experience may be substituted for degree

• A minimum of 4 years’ experience in clinical practice, pharmacy practice or within Pharmacovigilance; experience in Pharmacovigilance case processing and or triage is preferred

• Excellent presentation, interpersonal, and communication skills

• Experience with safety database, MEDdra preferred

• High proficiency in PowerPoint, Word, Outlook and Excel

  We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

  At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

  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.