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

Oversee the electronic submission program for US Patient Safety, ensuring adherence to Federal regulations and company Standard Operating Procedures (SOPs) related to Adverse Event (AE) reporting. This includes supervising both electronic and paper submission processes. Design, develop, and manage tools utilizing SQL based applications. Prepare and manage aggregate reports for submission to regulatory health authorities. This role will also be responsible for analyzing data trends and generating internal reports on AE and complaint information.

This role is responsible for analyzing data trends and generating internal reports related to Adverse Events (AE) and complaint information. Extract relevant safety data (AE/complaints) from safety databases for both internal and external reporting purposes, including submissions to Health Authorities, primarily the FDA. Additionally, manage projects focused on upgrading and enhancing safety technology systems.

Relationships

This position reports to the Director, Case Review & Compliance Reporting within Patient Safety.

This position works closely with the Patient Safety Case Management teams, NNI IT, Global Safety, GS Bangalore, and US Regulatory Affairs. External contacts include the FDA, NNI customers and NN business partners and contractual suppliers.

Essential Functions

• Administration
  • Determine and implement strategies consistent with the unit's functional and corporate goals
  • Optimization and automatization of report generation and preparation
  • Preparation of ad hoc and advanced listings by use of additional software and programming
  • Responsible for preparation of internal recurring reports for Patient Safety and relevant NNI stakeholders
  • Ensures that the US Safety Data Analysis function meets the needs of US PS, GS and Clinical Development
  • Manage IT projects in coordination with IT, suppliers, Global Safety and Patient Safety Management to upgrade and improve the functioning of various safety systems
  • Generate and prepare safety listings to appropriate internal departments
  • Liaise with Global Safety particularly IT and Quality Coordination
  • Liaise with outside vendors and corporate partners on safety monitoring issues as appropriate
  • Responsible for the development of this area's programs and fully accountable for adherence to timelines
  • Design, Develop and Manage tools which are being used locally or globally to facilitate business processes
  • Generate and prepare safety listings to appropriate internal departments, e.g. Medical
  • Develop and maintain company (safety) SOPs
  • Ensure compliance with all Federal regulations and company SOPs regarding complaint handling and regulatory reporting for adverse experiences, marketed product and clinical investigations
  • Maintain high state of knowledge of AE regulations, guidelines and standards related to AE surveillance and regulatory reporting including electronic submissions
  • Manage the processing and submission of safety reports including electronic submissions, IND safety reports and Medical Device Reports. Collect, review and edit documents necessary for safety reporting sections of periodic and annual reports
  • Retrieve complex safety data ongoing and on urgent requests from Authorities
  • Maintain applicable AE training programs relevant to electronic submissions
  • Prepare reports and other documentation to assist with audits and inspections, both internal and by regulatory authorities
  • Support audits and inspections with the timely delivery of the listings and reports from the database. Also participate in the audit and address questions pertaining to submissions
  • Write database queries using different reporting tools based on requests from both the regulatory authorities and internal management

Physical Requirements

0-10% overnight travel required.

Qualifications

• A Bachelor’s degree required with a minimum of 6 years of experience in quality, clinical and/or safety reporting experience or relevant work experience; advanced degree preferred
• Computer programming experience, preferably in SAS and/or SQL
• Documented experience from work utilizing databases, preferably as data manager in the pharmaceutical industry
• Documented experience in successful handling of change processes, in e.g., IT projects
• Excellent oral and written communication skills
• Knowledge of FDA safety, GCP and GMP regulations
• Previous pharmaceutical industry experience preferred
• Proven ability to monitor and track and develop programs and adhere to timelines
• Proven knowledge of Software tracking packages: knowledge of ARGUS a plus
• Ability to manage the application, communication and modification of policies and SOPS
• Knowledge of ARGUS preferred
• Knowledge of ICH and FDA safety as well as cGMP regulations
• Knowledge of Infopath and SQL server is preferred
• Knowledge of operating systems (Windows, Unix and Linux), relational database architectures, query languages and interfaces, standard programming environments, data integration tools, application integration solutions, and web-based information solutions
• Knowledge of product development process including GCP and FDA requirements for clinical design and post-market monitoring/reporting
• Knowledge of programming in SAS and Oracle is preferred
• Knowledge of programming tools such as TOAD is preferred
• Proven ability to monitor, track and develop programs, and adhere to timelines
• Proven experience as point-of-reference for scientific and filing questions
• Proven knowledge of software tracking packages

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.