Director - Patient Safety - Case Management - Plainsboro, United States - Novo Nordisk

Novo Nordisk
Novo Nordisk
Verified Company
Plainsboro, United States

3 weeks ago

Mark Lane

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Mark Lane

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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


Oversees the processes and resourcing for case intake, prioritization, coding and evaluation of all technical complaints and adverse events reported to NNI Patient Safety for marketed products.

Serves as the lead of the Case Processing Group.

Provides support and escalation channels for PS intake, phone inquiries from patients and healthcare professions and case processing issues. Serves as an expert regarding case processing issues and required documentation and investigation of product complaints. Serves as the key contact person between NNI Patient Safety, safety vendors and other departments for product complaint issues. Key contributor to NNI Patient Safety innovation projects related to case processing activities.


Relationships
Reports to the Executive Director, NAO Patient Safety with cross-functional working relationships within Medical,

Regulatory, Marketing, QA, Legal and IT.

This person will provide direct guidance to a team of Associate Managers, intake associate managers and directly and indirectly to case processing specialists and associates.


This position works closely with counterparts in the GS Departments, including Safety Operations, IT & Quality and Customer Complaint Center.

External relationships include interactions with patients, health care professionals. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department objectives.


Essential Functions

ADMINISTRATION:

  • Serves as a delegate for Executive Director for collaboration with Document Management team and Regulatory Affairs to ensure proper maintenance, retention and archiving of all Patient Safety records.
  • Serves as support to the management team for collaboration with GXP Support and Global Safety to develop training standards on adverse event data collection and reporting for the appropriate NNI staff.
  • Develops, maintains and continuously optimizes common processes for adverse event data collection and delivery, reconciliation, drug and event coding, adverse event reporting and Technical complaints.
  • Resource planning in collaboration with PS Director, GS in HQ and GBS
  • Collaborates with NNI PS Management and leads employees involved in the processing and evaluation of adverse event cases and ensures that adverse event information is processed according to corporate timelines and quality standards.
  • Coaching partner for all direct and indirect reports, including others in PS Management Team.
  • Provides expert assistance to colleagues in other departments in relation to safety activities.
  • Serves as the Lead of the Case Processing Team and Patient Safety Management Team.

FDA AND ICH COMPLIANCE:

  • Applies knowledge of industry regulations and practices regarding Patient Safety to follow the North American Regulatory requirements and SOPs and practices regarding Adverse Event processing and reporting.
  • Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH as well as other industry sources of information concerning current standards for safety and FDA reportability.
  • Serve as the backup Pharmacovigilance responsible person for NNI.

PRODUCT COMPLAINTS:

  • Ensures high quality medical and technical product information to health care professionals and patients relating to Patient Safety.
  • PRODUCT COMPLAINTS AND ADVERSE EVENTS:
  • Oversees investigations into adverse drug and device reports with Novo Nordisk products with respect to applicable Federal regulations (IND, NDA, MDR, GMP) and internal SOPs.
  • Oversees the intake, triage and case processing of adverse medical events and malfunction reports with respect to FDA reportability (ie. 7 day, 15 day, MDR).

Development of People

  • Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
  • Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the ach
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