Novo Nordisk Hiring MBBS/MD Graduates- Safety Surveillance Adviser I Post

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Novo Nordisk, a global pharmaceutical leader, is currently seeking a Safety Surveillance Adviser I with an MBBS/MD background. This role offers an exciting opportunity to contribute to the safety and well-being of patients while working in a dynamic and innovative healthcare organization. Latest MBBS and MD Jobs at Novo Nordisk – As a Safety Surveillance Adviser I, you will play a crucial role in ensuring the safety of Novo Nordisk’s products, making a meaningful impact on healthcare worldwide. Join our team and be part of our mission to change lives for the better.

Post Title: Safety Surveillance Adviser I

Company: Novo Nordisk

Location: Bengaluru, Karnataka, India

Employment Type: Full-Time

Deadline: 15th October, 2023.

Educational Qualification: Masters in Medicine/MD post-MBBS graduate is Preferred

Qualification:

  • Relevant Experience in Signal Management, Aggregate Management, ICSR.
  • Comfortable user of Microsoft Office package (Outlook, Word, Excel, and PowerPoint).
  • Fluent in written and spoken English.
  • Analytical mind-set.
  • Professional authority.
  • Quality mindset, well-organized, and strive for excellence.
  • Pro-active planner to meet agreed deliverables.
  • Strong communicator (verbally and in writing).
  • Curious and constantly looking for improvement opportunities.
  • Team player with a high degree of flexibility and service-mindedness.
  • Cross-cultural awareness.
  • Ability and willingness to quickly adjust to changes in a continuously developing environment.

Roles and Responsibilities:

  • As a Safety Surveillance Adviser, you will be responsible for the establishment of the product safety profile during the development and maintenance of the labeling for marketed products.
  • Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities (HAs), as required.
  • You will be required to establish, operate, and chair the NN cross-functional safety committee throughout the lifecycle of the actual product – present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements/recommendations.
  • You will be responsible for all areas related to patient safety in clinical trials.
  • Act as Owner of the safety sections of the labeling for the evolving Company Core Data Sheet (CCDS) for development products. Maintenance of labeling for marketed products and participation as labeling change request (LCR) reviewer and providing safety input as LCR reviewer.
  • As an author, you will prepare relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs). Respond to requests from HAs and internally from NN affiliates.
  • Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator’s Brochure (IB), integrated safety summaries, abstracts, and planned publications.
  • You will provide proactive safety communication by participating in project/trial groups/teams established, as appropriate, and conduct Investigator training as required.
  • Provide answers to inquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs).

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