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Safety Surv Medical Writing Specialist

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Job Specifications
Employment Type Full time jobs
Job Description

Team
:
Safety Medical Writing, Safety Surveillance, Global Patient Safety
Location
: Bangalore, Novo Nordisk Global Business Services (GBS), India
Are you passionate about ensuring patient safety through meticulous scientific writing? Do you have the expertise to handle complex safety surveillance reporting? We are looking for an experienced Safety Medical Writer to join our team and lead high:complexity tasks related to safety reporting. If this sounds like you, read on and apply today for a life:changing career
The position
As a Safety Medical Writing Specialist at Novo Nordisk, you will:
:
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Be responsible for the preparation of complex aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority questions.
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Collaborate with cross:functional teams, , to ensure high:quality scientific writing and timely reporting of safety data.
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Contribute to the evaluation and implementation of changes in local/global guidelines to ensure compliance with internal and external requirements.
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Contribute to innovation and technical optimization projects within Safety Medical Writing to enhance efficiency, quality, and scalability of deliverables.
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Drive process improvement activities, medical writing competency development and skill building across Safety Medical Writing.
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Act as an expert for junior team members, share information, and take proactive steps to excel in your role.
Qualifications
We are looking for candidates with the following qualifications:
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A master 's degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological), combined with proven experience (:8 years working within pharmacovigilance and medical writing).
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Excellent analytical and communication skills.
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Solid understanding of pharmacovigilance and of drug development in general.
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Expert understanding of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) and RMPs, and the guidelines and regulations that drive their preparation.
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Experience in applying artificial intelligence/structured authoring or other technical solutions in medical writing
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Highly collaborative, capable of leading cross:functional team members, negotiating solutions, advising them on document structure and content as needed.
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Able to handle multiple projects simultaneously and deliver multiple high:quality documents on schedule
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Fluency in both written and spoken English (business language) and flair for written scientific communication and data presentation.
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Experience in handling documents of high complexity (e.g., submissions of Marketing Authorization Applications) or prior experience in performing specialist tasks will be considered an advantage.
About the department
Safety Medical Writing is a global team within Global Patient Safety, situated in Bangalore, India and S borg, Denmark. Safety Medical Writing delivers expertise in regulatory pharmacovigilance documentation to ensure that the safety data of our products is presented clearly and concisely in documents that are fit:for:purpose, with transparency and ethics being our key drivers.
Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.
Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Deadline
31st January 2026
Disclaimer
It has been brought to our attention
Job Type: Permanent
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TipTopJob (Registered since June-2013)
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