Manager Safety intelligence & Compliance Job
Purpose
To contribute and support activities related to Adverse Event reporting and quality tasks in order to ensure consistency and compliance in all functions performed by Product Safety. To ensure maintenance and development of quality activities in Product Safety including, but not limited to, compliance tracking as well as various functions (e.g. evaluation of Time Limit Exceedings and Quality Control (QC) results in collaboration with Global Safety, contractual arrangement support, vendor support in regards to safety reporting, etc.).
Relationships
This position reports to the Director, Safety Intelligence & Compliance. This position works closely with all units in Product Safety, Novo Nordisk Inc. (NNI) Quality Assurance (QA), Commercial Effectiveness, Marketing as well as Global Safety. Interacts with senior external contacts on significant matters, including the Food and Drug Administration (FDA), customers and vendors.
Essential Functions
Primary: Administration: Exercises considerable latitude and applies extensive technical expertise in determining and implementing strategies consistent with the unit’s functional and corporate goals. Prepare non-conformity reports when appropriate. Responsible for ensuring regular review and maintenance of Product Safety GlobeShare site. Responsible for preparation of monthly and annual Time Limit Exceeding Memo for Head of Product Safety/QA department. Memos require analysis of late reports that occur during the month, preparing root cause analyses, review the data for trends and make recommendations for process changes and other corrective actions to prevent future late reporting and improve FDA reporting compliance. Collaborate with other departments within Product Safety, other business areas at NNI and Global Safety to ensure late reports have been correctly identified and reported to management. Directs employees on proper root cause analysis, identification and documentation. Supports internal and external training activities, such as Introduction program for new employees in Product Safety, safety training for all employees in NNI, and safety Training at Plan of Action (POA). Performs review of contracts with vendors involved in customer related activities on behalf of Novo Nordisk. Provides guidance to contract owners and other stakeholders on safety reporting requirements, including Safety Data Exchange Agreements. Liaise with outside vendors and corporate partners on electronic safety monitoring and reporting issues as appropriate. Provides Product Safety overview of Patient Support Programs, Market Research Programs, Other Customer Engagement Programs and Partners. Responsible for preparation of internal monthly reports for Product Safety management and, as needed, Executive Team (ET) and Clinical Medical Regulatory (CMR).
Primary: Guides the successful completion of major programs and may function in a project leadership role.
Primary: Regulatory Compliance: Ensures compliance with all Federal regulations and company Standard Operating Procedures (SOPs) regarding adverse event reporting from both post-marketing sources and clinical trials complaint handling. Maintain high state of knowledge of Adverse Event regulations, guidelines and standards related to Adverse Event surveillance and regulatory reporting. Participates in Promotional Review Board (PRB) meetings for all assigned NN products. May be tasked with review of documents necessary for safety reporting sections of periodic and annual reports (e.g. Periodic Safety Update Report (PSUR), Drug Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), Investigational New Drug (IND) Annual etc.) depending on background and business need.
Secondary: Business Partner Liaison: Liaise with outside vendors and corporate partners on safety monitoring issues as appropriate. Serve as primary contact, facilitator and communicator of information to other departments within NNI and Novo Nordisk A/S (NNAS) concerning adverse events and technical complaints. May assist with the processing and submission of expedited safety reports depending on background and business need. Develop and maintain company (safety) SOPs. Develops applicable Adverse Event training programs.
Qualifications
- A Bachelor’s Degree in science area with a minimum of 8 years’ experience required; or a Registered Nurse or R.Ph with a minimum of 5 years’ experience, including 3 years in clinical and/or safety reporting. Advanced degree preferred
- An MD in lieu of RN or Bachelors would be acceptable equivalent experience
- Database and word processing experience
- Excellent oral and written communication skills
- Knowledge of diabetes and diabetes management
- Knowledge of FDA safety and Good Manufacturing Practice (GMP) regulations
- Prefer experience leading projects in a clinical and/or safety area
- Previous pharmaceutical industry experience preferred
Novo Nordisk is an Equal Opportunity Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
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.
Requisition ID: 57321BR
State/Provinces: Plainsboro
Job Category: Regulatory
Requirements:
Compliance, Database, Defense, Diabetes, Government, Healthcare, Law, Legal, Management, Manager, Market Research, Marketing, Marketing Manager, Medical, Nursing, Pharmaceutical, QA, Quality, Quality Assurance, Registered Nurse, Research, Safety, Science, Service, Special Medicine, Technology
