- Pharmacovigilance
- Bangalore
Looking for Safety Medical Writers!
Are you looking for a job to unlock your Medical Writing skills? Apply for the position of Safety Medical Writer to have life changing career!
About the department
Novo Nordisk Service Centre India Pvt Ltd, responsible for the development of diabetes medicines. Novo Nordisk has a long and outstanding track-record of developing the best, most innovative and widely-used injection devices in the world. We are located at Bangalore.
The Job
Be responsible for the planning and preparation of:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs/PBRERs
Risk Management Plans (RMPs)
Are you looking for a job to unlock your Medical Writing skills? Apply for the position of Safety Medical Writer to have life changing career!
About the department
Novo Nordisk Service Centre India Pvt Ltd, responsible for the development of diabetes medicines. Novo Nordisk has a long and outstanding track-record of developing the best, most innovative and widely-used injection devices in the world. We are located at Bangalore.
The Job
Be responsible for the planning and preparation of:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs/PBRERs
Risk Management Plans (RMPs)
- through development to submission
- post-marketing
- Responses to any safety questions raised in connection with assessment reports
Other relevant ad-hoc documents
Contribution to knowledge sharing, skill building and good collaboration with stakeholders and colleagues:
You will also have an opportunity to participate in internal/external marketing/medical activities, e.g., expert meetings, lectures and conferences
Contribute to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
Contribute to process improvements
Maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas
Actively participate in relevant meetings, training sessions and seminars in the department, competency anchor and relevant project(s)
As Product responsible Safety Medical Writer, you will:
Act as mentor/trainer for other safety medical writers working with the product, as required.
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 the prioritisation of tasks
Perform consistency review of documents as back-up SMW
contribute to the evaluation of safety data from clinical trial and spontaneous sources
Qualifications
Graduate (MSc, MBBS, BDS/MDS, B.Pharm/M.Pharm, B.V.Sc.&A.H or equivalent)
≥3 years of experience in Pharmacovigilance as Medical Writer/Pharmacovigilance writer/Advisor.
Experience with scientific writing in English (publications or equivalent)
Novo Nordisk is an organisation with many international employees. Here, you will get the opportunity to be a part of a global team that fosters great work culture, work independently and play an active role in the growth of the team through knowledge sharing and skill building and in addition enhance your career, benefiting from the possibilities for professional and personal development provided by Novo Nordisk.
At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working at Novo Nordisk is not just a way to make a living, but a way to make a difference.
Contact
For further information, contact Lavanya Sadashiva at +91 80 39988645
Deadline
1 December 2014
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