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Safety Medical Writer - India  

Novo Nordisk (company)


Posted on : 10 April 2017

Project Description

Job Description
  • Opening for Safety Medical Writer
  • Are you looking for a role as Safety Medical Writer? 
  • Join our company  Global Service center to have a life changing career!!!

About the department
Global Safety:
  •  The department the Global Service Center responsible for processing ICSRs and for performing Safety Surveillance activities.
  •  Global safety has an outstanding track-record in case processing and writing/publishing aggregate reports.
  •  You will join a team of highly motivated employees, responsible for the safety of the patients.

The Job
  • The job is a permanent position.
  • You will become a member of the safety surveillance team which is responsible for aggregate reporting. 
  • You will especially focus on defining and integrating user/stakeholder requirements and safety risk management. 
  • You will be given a number of different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. 
  • The job will enhance your professional and personal development, providing you with an opportunity to develop skills within specialist expertise and project management.

Medical Writing
  • Plan, drive, and co-ordinate preparation of documents to ensure submission according to the submission plan, or as otherwise agreed with Regulatory affairs.
  • Contribute to continuous resource planning process in collaboration with immediate superior – including identifying medical writing tasks and assist in prioritization of tasks
  • Perform consistency review of documents as back-up SMWAct as mentor/trainer for other safety medical writers working with the product, as required.
  • Perform medical writing tasks in Safety Surveillance including planning and preparation of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs/PBRERs),  Risk Management Plans (RMPs)Responses to any safety questions raised in connection with assessment reportsInput to -  investigational new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs), and investigational medicinal product dossiers (IMPDs) and other relevant ad-hoc documents 

  • Medical Doctor, Dental doctor, Master degree in pharmacy or equivalent medical and scientific background.
  • Experience with scientific writing in English (publications or equivalent)
  • Specific personal and job-related demands (communication skills, ability to take initiative, flexible attitude, ability to work independently/in a team, personal traits necessary in the job, etc.).
  • Open and honest
  • Analytical
  • Systematic and organised
  • Proactive
  • Goal oriented
  • PersistentInnovative
  • Good team playerGood at sharing knowledge