Position

Senior Drug safety Associate for Clinical Trial Case Processing

Job description

Job description

Location

Bangalore, India

Job category

Clinical Development and Medical

   

We are looking for a Senior Drug Safety Associate in Global Safety (GS) unit based out of Global Business Service (GBS), Bangalore, India. You can look forward to an exciting job driving different projects and engaging with multiple stakeholders at the global level.

 

The position

As a Senior Drug Safety Associate you handle non-serious, serious adverse events and training. You 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.

 

You 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 listedness for all cases. You 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. You should work within strict timelines.

 

You ensure that all tasks are performed in compliance in accordance to 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. You participate in projects in Global Safety or in other parts of the organisation which impacts processes in Global Safety. You liaise with affiliates and partners for local literature and compliance. Liaise with Safety Reporting and IT in all aspects of data retrieval and custom reporting. Participate in inspections and audits when required.

 

You assist with related administrative and procedural activities as required or requested. Independent decisions making regarding evaluating the submission of adverse event reports. Ensure compliance with the training plan provided for the role. You act as a buddy for colleagues and provide trainings as required. Contribute to process improvements.

 

Qualifications

You need to have the below knowledge and skills.

  • Extensive knowledge of medicinal terminology and clinical pharmacology as well as knowledge of patient treatment, diagnostic investigations and pathology.
  • Solid knowledge of pharmacovigilance principles and international regulatory requirements regarding drug safety
  • Solid experience with IT, including MS Office (Word, Excel, Outlook, Powerpoint) and data entry
  • Speaks and writes English at a professional level
  • Solid Novo Nordisk organizational or pharmaceutical company understanding
  • Basic knowledge of Novo Nordisk products, incl. mechanism of action, safety profile, patient population, etc
  • Good knowledge of GXP requirements
  • Knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety
  • Smart, analytical, time manager, effective communicator

 

About the department

Global Business Service (GS-GBS) was set up in 2010 as one of the hub for safety case processing. At GS-GBS, we handle case processing from different sources including spontaneous, literature, solicited and clinical trials. Apart from complete case processing and medical review, GS-GBS is also engaged in safety report submission, training, LearnIt administration, quality control of individual case safety reports (ICSR), ARGUS configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring.

 

Working at Novo Nordisk

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. We create value by putting patients first. Working here is not just a way to make a living, but a way to make a difference.

 

Contact

For further information please contact Vaibhav at VBKE@novonordisk.com

 

Deadline

31 October 2021

Millions rely on us 

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.