Novo Nordisk Hiring Drug Safety Expert-I

Novo Nordisk Hiring Drug Safety Expert-I

16 May, 2022

About the job

“Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease. We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us. It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile.

We are looking for a potential candidate in our Drug Safety Expert unit which involves high level of co-ordination with colleagues at SO-DK and affiliates, requiring frequent travel. The position is based in Bangalore.

The position
As a Drug Safety Expert unit, you will be the one who set and achieve day-to-day operations with some impact on others within or outside the unit. Handling of non-serious and serious adverse events. Training on the process. Actively participate in audits and inspections. Ensure cross organizational communication and cooperation; and support implementation of new processes based on increased regulatory requirements and in accordance with GS’s strategic framework. SOP author. Typically reports to a Head of the Project

Handling Of Non-serious And Serious Adverse Events

  • Perform initial evaluation of reported adverse events (serious and non-serious) from all sources.
  • Perform case entry and verification of reported non-serious and serious adverse events; enter
  • the reported information in the Novo Nordisk safety database – Argus, based on individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments.
  • Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities).
  • Evaluate causality, seriousness, and listed ness for all cases.
  • Ensure that case narrative comprises correct and appropriate safety information.
  • Assess the need for follow up information and issue follow up requests for all cases and post
  • queries in EDC and/or to affiliate.
  • Perform weekly literature surveillance related activities.
  • Ability to work within strict timelines.

In Addition

  • Ensure that all tasks are performed in compliance in accordance with GXP requirements.
  • Maintain a network of safety contacts within Global Safety (GS) and affiliates.
  • Communicating with the SO-DK and affiliates to query and/or clarify the details related to the
  • safety data.
  • Having extensive knowledge of Novo Nordisk global safety database (Argus) and Global
  • customer complaint system (CCGloW).
  • Must be owner or involved in the creation and maintenance of standard operating procedure.
  • Global Safety processes.
    • Assist/provide response to health authority requests.
    • Support implementation of new processes and/or requirements based on increased regulatory requirements.
    • Ensure cross organizational communication and cooperation with regards to safety information

This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management, communication skills. Ensure quality of submissions by complying to procedures and systems.

Qualifications

Below are the required skills.

  • Graduation and /or Post Graduation in (life Sciences)
  • 7 – 10 years of experience in a similar environment.
  • Sound knowledge of Pharmacovigilance is expected.
  • Knowledge of medical terminologies and clinical pharmacology.
  • Good understanding of the internal and external Pharmacovigilance setting and requirements.
  • Sound working knowledge of MS Windows applications including MS Office tools.
  • Solid Novo Nordisk organizational or pharmaceutical company understanding.
  • Excellent communication skills (written and oral), with English correspondence.
  • Good presentation skills
  • Solid knowledge of Novo Nordisk products, incl. mechanism of action, safety profile, patient population, etc.
  • Well versed with CAPA (Corrective and Preventive Action) process.
  • Expert in Case Management Request vertical.
  • Good knowledge of GXP requirements.
  • Solid knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety

Apply through this Link

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