- Training:
- Ability to perform all responsibilities of more junior staff, including but not limited to:
- 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 and external PV stakeholders
- 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 Patient Safety staff training and development progress and provide assessment feedback to employees and manager(s) as needed
- Develop and lead internal and external trainings related to safety
- Identify training and learning gaps (i.e. areas for improvement), make recommendations and lead implementation of training solutions for internal and external safety staff and suppliers in alignment with Patient Safety leadership and input from functional area Subject Matter Experts
- Support development and maintenance of Patient Safety eLearning modules on the Learning Management System (LMS)
- Perform call monitoring and lead call QC callibration of Patient Safety calls as it relates to training progression
- Lead 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
- Lead and author updates to 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 medical or Science related discipline required; relevant experience may be substituted for degree
- 6 years progressive responsibility experience in relevant pharmacovigilance adverse event reporting
- Experience in Pharmacovigilance training or mentorship is preferred
- Knowledge of medical terminology
- Excellent presentation, interpersonal, and communication skills
- Experience with safety database, MEDdra, Adverse event case assessment and triage; 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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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Associate Manager - Plainsboro, United States - Novo Nordisk
Description
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
Responsible for leading review and approval of training related materials, documentation and delivery of training for Patient Safety (PS) employees' onboarding and on-the-job training for pharmacovigilance as well as Safety training conducted for internal and external stakeholders.
Identify training and learning gaps and implement solutions with alignment with Patient Safety leadership. Coordinate and support continued development of Patient Safety staff through training. Leads 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 regard to Patient Safety training. External relationships include interaction with vendors and other supplier to Safety.
Essential Functions
