Novo Nordisk Safety Medical Writer Vacancy – B Pharma & M Pharma
Pharma job opening 2022. Safety medical writer job opening 2022. Pharmacy job opening 2022. Safety writer job opening 2022. Novo Nordisk pharma job opening 2022. Candidates with master’s and bachelor’s degrees in pharmacy may apply for the job opening at Novo Nordisk. Check out all the details on the same below:
Job Title: Safety Medical Writer
Location Bangalore, India
Job category Clinical Development and Medical
Below skills are required:
- Any graduate with Pharma/ Healthcare/ Life science background i.e BSc, Bpharm, MPharm, Ph.D. Or equivalent
- 2+ Years of relevant working experience within some of the key professional competencies Clinical/CRO/Pharma Industry
- Strong understanding of Microsoft office package (Outlook, Word, Excel and PowerPoint)
- Strong verbal and written communication
- Strong analytical skills
- Professional authority
- Quality mind-set, well-organized and strive for excellence
- Pro-active planner to meet agreed on deliverables
- Strong communicator (verbally and in writing)
- Curious and constantly looking for improvement opportunities
- Team player with a high degree of flexibility and service mindedness
- Cross-cultural awareness
- Ability and willingness to quickly adjust to changes in a continuously developing environment
About the department
Global SafetyGlobal Business Service (GS-GBS) was set up in 2010 asone of the hubs for safety case processing. At GS-GBS, we handle case processing from different sources including spontaneous, literature, solicited, and clinical trials. Apart from complete case processing and medical review, GS-GBS is also engaged in safety report submission, training, LearnIt administration, quality control of Individual Case Safety Reports (ICSR), Argus configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring.
- As a Safety Medical Writer, you would be involved to plan, driving, and co-ordinate the preparation of safety documents to ensure submission according to agreed timelines. You will prepare Development and Periodic Safety Update Reports (DSURs and PSURs) in collaboration with relevant stakeholders for submission worldwide.
- Further, you would be responsible to initiate and prepare updates of Clinical Risk Management Plans in collaboration with relevant stakeholders for regulatory submissions worldwide and ensure consistency between this document and other relevant clinical documents.
- You will also perform a consistent review of documents as a backup SMW. You are expected to actively contribute to knowledge sharing, skill building, and good collaboration with stakeholders and colleagues. Your task will involve maintaining a good working relationship with stakeholders and colleagues and contributing to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge.
- You will maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas. Also, actively participate in relevant meetings, training sessions, and seminars in the department and ensure that documents are in accordance with Novo Nordisk SOPs and external guidelines.
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