Safety Medical Writer

2 weeks ago

Bengaluru, India Novo Nordisk Full time

**Department - GS GBS Safety Medical Writing**

**The Position**

As a Safety Medical Writer (SMW), you will plan, drive and co-ordinate preparation of safety documents to ensure submission according to agreed timelines. You will prepare aggregate safety reports, clinical risk management plans and responses to questions from health authorities in collaboration with relevant stakeholders, for submission worldwide. Additionally, you will also contribute to knowledge sharing, skill building and collaboration with stakeholders and colleagues. You will also be expected to:

- Maintain a good working relationship with stakeholders and colleagues.
- Contribute to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge and process improvement.
- Participate in internal/external medical/medical writing activities.
- Maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas.
- Support the onboarding of new SMWs by providing training and mentorship on process or report related activities and provide support to other safety medical writers working with the product, as required.

**Qualifications**
- You either hold a higher degree in a biological/pharmaceutical science/medicine (PhD, Master or equivalent), or have a relevant degree with work experience in the medical or pharmaceutical field.
- You have a demonstrated aptitude and genuine interest in scientific communication and strong command of English. In addition to this, you have:

- a good eye for detail and logical structure.
- experience working with datasets.
- strong analytical competencies.
- an understanding of drug safety during drug development would be an advantage.
- fluency in both written and spoken English (the business language) and solid experience using MS Office.
- You thrive in a multicultural environment of continuous development, and you are good at establishing contact, communicating, collaborating with colleagues, as well as challenging them.
- You have strong planning, and project management skills.
- You have high ethical standards and can prioritise your tasks and rise to challenges.

**About the department**

Global Safety Global Business Service (GS-GBS) was set up in 2010 as one of the hubs for safety case processing. We handle case processing and medical review of Individual Case Safety Reports from different sources (spontaneous, literature, solicited and clinical trials). We are additionally engaged in safety surveillance, safety medical writing, safety report submission, training, quality control of ICSRs, Argus configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring.

**Working at Novo Nordisk**

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

**Contact**

**Deadline**

23rd January 2023

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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