Drug Safety Expert-I

Category:  Clinical Development and Medical
Location: 

Bangalore, Karnataka, IN

   

 

“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
     

Working at Novo Nordisk

At Novo Nordisk, we strive for excellence. You share the same passion and commitment as our employees in our journey to make a difference to patients’ lives. In exchange, we offer you the chance of a lifetime to work with extraordinary talent and benefit from unmatched opportunities for professional and personal development.
 

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions). 

 

Deadline

July 8, 2022

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.