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Drug Safety Associate - India  

Novo Nordisk (company)


Posted on : 27 March 2017

Project Description

Job Description
  • Our company  is one of the world’s most successful pharmaceutical companies with a great growth potential.
  •  Do you want to be part of this?
  • Safety Operations  is part of Global Safety who has the global responsibility for surveillance of the Safety and Quality of our company clinical development and marketed products. 
  • Safety Operations  is responsible for global handling and reporting of adverse event reports.

Position Description
As a Drug Safety Associate you will be part of a young and dynamic team currently consisting of 63 dedicated employees.

Responsibilities include
  • 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 company safety database, on the basis of 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 listedness 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
  • To be responsible for Periodic Safety Update Report (PSUR) clean up and other case clean-up activities.
  • 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.
  • Participate in projects in Global Safety or in other parts of the organisation with impact in Global Safety processes.
  • 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.
  • 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.
  • Act as a buddy for colleagues and provide training as required
  • We also expect you to take an active part in the continuous development of the growing department.

Typical knowledge and specific experience
  •  Good communication skills (written and oral), with English correspondence.
  • Basic working knowledge of MS Windows applications including MS Office tools.
  • Basic knowledge of Pharmacovigilance and medicinal terminologies and Clinical Pharmacology.
  • Basic knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety.
  • Basic  organizational or pharmaceutical company understanding.
  • Basic knowledge of company products, incl. mechanism of action, safety profile, patient population, etc

Personal skills
  •  Self-motivated and proactive.
  • Quick learning and analytical skills.
  • Ability to take up initiatives.
  • Team oriented personality with high degree of flexibility.
  • Ability to capture attention and motivate a team around discussion.
  • Ability to work independently and within strict timelines.
  • Attention to detail and quality.
  • Willingness to occasionally work at unusual times.
  • Strive for continuous improvement.