Prabhdeep Singh

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Associate Director - Medical Review Job

Date: Feb 21, 2019

Location: Plainsboro, NJ, US

Company: Novo Nordisk

About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk Inc (NNI) 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 Food and Drug Administration (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 performing medical review and validation of incoming adverse events, ensuring the correct medical interpretation, including evaluation of expectedness and reportability. Ensures consistency in the evaluation of Adverse Event cases. Assures compliance and fulfillment of the requirements as to the evaluation, reporting and surveillance of clinical and post marketing safety information with US drug and device safety reporting regulations and ICH guidelines and internal procedures.
The Associate Director Medical Review will contribute and maintain the safety profile of the company’s product together with HQ.

Reports to the Director of Safety Reporting and Compliance, with cross-functional working relationships within Medical, Regulatory and Marketing. Interacts with counterparts in Safety Operations, Global Safety. Provides medical and technical information to health care providers relating to product safety. Serves as an internal advisor regarding safety issues.

Essential Functions
Liaise with local product safety, as well as medical, clinical and regulatory, on all relevant safety matters. Narrative writing, medical evaluation of a case, reconciliation of databases, review of protocols, etc. Provides medical input in the safety review of Individual Case Study Reports (ICSRs) where the US affiliate has case processing responsibilities, namely post-marketing sources. Responsible for performing review of individual safety reports for medical content, evaluation of expectedness/listedness and assessing regulatory status for expedited reporting, and possible signal detection. Performs aggregate medical review of post-marketing, non-serious adverse events in collaboration with Global Safety. Handles local aggregate report activities, incl. review and safety input for assigned products, e.g. for Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs),Periodic Adverse Drug Experience Reports (PADERs) and Investigational New Drug (IND) Annual Reports. Collaborate with Safety Operations in HQ, drug information and technical product information to evaluate safety data.

Utilize knowledge of industry regulations and practices regarding product safety to follow the North American Regulatory regulations and SOPs and practices on Serious Adverse Event (SAE). Participates in PRB meetings for all assigned NN products. Assists in determination of regulatory submissions for ICSRs and performs the quality check of the assessments in collaboration with the case processing teams. Complies with all Federal regulations and company SOPs regarding complaint handling and regulatory reporting for adverse experiences, marketed product and clinical investigations. Maintains high state of knowledge of AE regulations, guideline and standards related to AE surveillance and regulatory reporting. Provides Product Safety input to assigned product’s Local Labeling Committee. Provides input to Product Safety requirements in relation to various programs (e.g. social media, Patient Support Programs, Market Research Programs, Registries, etc.). Reviews and disseminates information from the affiliate mailbox.

Physical Requirements
0-10% overnight travel required

  • An M.D. /D.O. required, with up-to-date knowledge of clinical and therapeutic principals.
  • Minimum of one-year pharmaceutical industry experience required.
  • Computer literacy required.
  • Excellent communication Skills – written and verbal English are of significant importance to success in this position.
  • MedDRA coding experience required.

Novo Nordisk is an Equal Opportunity Employer /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: 59397BR
State/Provinces: Plainsboro
Job Category: Regulatory

Nearest Major Market: New Jersey

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