Novo nordisk's data management department was established in Bangalore, India in the month of September 2007 and has significantly grown from 10 members to a strong team of over 140 Clinical Data Management professionals. It has witnessed significant transformations right from providing DM services to IO region reporting to IOCDC to becoming an integral part of Global development from Aug 2010. It is a young, enthusiastic and dynamic team with varied skillsets and professionals from diverse backgrounds such as pharmacy, life-sciences, physiotherapy, computer / information sciences and business administration.
Post : Safety Medical Writer
About the department
Global Safety: The department the Global Service Centre 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 and starts ASAP - latest 01 Jul 2017. 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 prioritisation of tasks
- Perform consistency review of documents as back-up SMW
- Act 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 reports
- Input 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
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Qualification
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.).
Additional Information:
Location: Karnataka
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance
Requisition ID: 46171BR
End Date: 5th May, 2017
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