Associate Safety Operations Adviser

2 weeks ago

Bengaluru, Karnataka, India Novo Nordisk Full time

Department:
Global Safety.

About the Department


Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed Products and is responsible for global handling and reporting of adverse events reports.


The Position


All tasks in the GS-GBS SO Safety Operations Advisers department demand a large professional insight, self-dependence, and competence in making decisions, as well as flexibility, a good comprehensive view and a many-functioned, often international, co-operation.

Ensure the fulfilment of global regulatory requirements to the collection, evaluation and reporting of safety information on Novo Nordisk (NN) pharmaceutical products i.e., spontaneously reported adverse events, serious adverse events (SAEs) from clinical trials, investigator sponsored trials, named patient supplies and third-party trials, ensure appropriate medical interpretation and evaluation of adverse events reported from world-wide sources, from marketed use.


To contribute to the collection, medical evaluation, and reporting (to the authorities) concerning adverse events from clinical use of Novo Nordisk's preparations and products in the post approval phase.

The tasks demand a large professional insight, self-dependence and competence in making decisions, as well as flexibility, a good comprehensive view and a many-functioned, often international, co-operation.

To be responsible for immediate reporting to the relevant authorities of serious adverse events that may be associated with Novo Nordisk's products.

Omission or a delay to do so can result in serious consequences for Novo Nordisk.

To be responsible for the medical evaluation of reports concerning serious adverse events, as well as for the evaluation of possible causal relationships.


  • To ensure the review and preparation of relevant follow up questions, consistency in handling clinical and postmarketing cases. To escalate critical adverse events/reactions to line manager and/or Safety Surveillance Adviser. Medical evaluation and medical review on all case types, as applicable. To review AE, pregnancy, and safety information forms (both electronic forms and paper forms). Monthly review of spontaneous non serious cases as noncases as nonserious line listings to ensure consistency in coding and listedness.
  • To participate in clinical project groups as well as safety meetings as needed and to ensure responsible coverage of safety areas. To review clinical protocols to ensure that all relevant safety information is captured through the procedures described in the protocol and to ensure that these procedures are in alignment with the workflow in Safety Operations. Point of contact providing support for Data Management colleagues if/when product queries arise.
  • To ensure accurate and consistent coding using MedDRA of all adverse events reported NN to ensure consistency and precision between projects, products and countries in the coding of adverse events. To ensure the review and preparation of relevant follow up questions.
  • To participate in the GS MedDRA Coding Group and Case Handling meetings as required. To ensure uptodate knowledge through participation in relevant courses and meetings and through reading relevant literature, regulatory guidelines and new media. To supervise reconciliation process of SAEs with the clinical trial data base. Ensure all tasks are performed in compliance to and in accordance with Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP) requirements.

Qualifications

  • Post graduate MD / MBBS with relevant Pharmacovigilance experience preferable.
  • Documented scientific experience, preferably from the pharmaceutical industry (0 to 1 plus years of experience.
  • Good knowledge of diseases, their clinical manifestations, treatment and complications.
  • Good knowledge of clinical pharmacology.
  • Good knowledge of computers and databases.
  • Fluent English, both written and spoken. Accountable, good planning and coordination skills.
  • Take initiative, systematic and organised, thorough and analytical.
  • Work independently in a team and manage projects.
  • Flexibility and good communication skills are necessary in the cooperation with other functions and departments in Global Safety, Global Development, NN affiliates and external collaborators.
  • Good understanding and knowledge of PV, clinical development and regulatory requirements are prerequisites for performing the tasks and for providing expert advice to internal and external stakeholders.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us t

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