Job for M.Pharm as Safety Medical Writer in Global Safety at Novo Nordisk

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).

Post : Safety Medical Writer in Global Safety

Job Description
About the department
The department within the Global Service Centre responsible for processing Individual Case Safety Report (ICSR) 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 position
• In this role you will be product responsible safety medical writer on the different products. You will need to plan, drive, and co-ordinate preparation of documents to ensure submission according to the submission plan, or as otherwise agreed with regulatory affairs. You should perform consistency review of documents as back-up Safety Medical Writer (SMW) and act as mentor/trainer for other safety medical writers working with the product, as required. You will have to perform medical writing tasks in Safety Surveillance including planning and preparation of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs). You will contribute to knowledge sharing, skill building and maintain a good working relationship with stakeholders and colleagues.

• The job will enhance your professional and personal development, providing you with an opportunity to develop skills within a specialist domain and project management. You will be travelling occasionally abroad to meetings, conferences, courses and on the job training when agreed with immediate superior.

Candidate Profile
• Medical Doctor, Dental doctor, Master degree in Pharmacy or equivalent medical and scientific background
• More than 3 years of experience in aggregate reporting (PSUR/DSUR/RMP preparation) (mandatory)
• Experience with scientific writing in English (publications or equivalent)
• Experience from the pharmaceutical industry is a major advantage but not a must
• Specific personal and job-related demands (managerial experience, communication skills, ability to take initiative, flexible attitude, ability to work independently/in a team, human resource responsibility, personal traits necessary in the job, etc.)
• Open and honest
• Thorough
• Analytical
• Systematic and organised
• Proactive
• Goal oriented
• Persistent
• Innovative
• Good team player
• Good at sharing knowledge

Additional Information
Qualification : M.Pharm
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Global Safety
End Date : 20th March, 2020