Patient Safety Training Specialist
5 days ago
About the Role
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is a dynamic and collaborative group within the organization.
As a key member of the CMR team, you will be responsible for coordinating and overseeing Patient Safety (PS) employees' onboarding and on-the-job training for pharmacovigilance, as well as Safety training conducted for internal and external stakeholders.
You will ensure 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.
Key Responsibilities
- Maintain a 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-train 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 records 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.
- 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 managers 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 managers with communication of safety information to others.
Requirements
- 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.
About Novo Nordisk
Novo Nordisk is a global healthcare company that is committed to creating an inclusive culture that celebrates the diversity of its employees, the patients it serves, and the communities it operates in.
We are an equal opportunity employer and welcome applications from qualified candidates 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.
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