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.
Post : Sr Safety Medical Writer
Job Description
As a Senior Safety Medical Writer, you will independently deliver complex writing assignments that sit at the heart of pharmacovigilance. Your expertise in aggregate safety analyses and regulatory documentation will ensure that the safety profile of Novo Nordisk's products is communicated with accuracy, compliance, and clarity — ultimately safeguarding patients around the world.
Your key responsibilities will include :
• Preparing complex aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority questions
• Collaborating with cross-functional teams to ensure high-quality scientific writing and timely reporting of safety data
• Evaluating and implementing changes in local and global guidelines to ensure compliance with both internal and external requirements
• Contributing to innovation and technical optimisation projects within Safety Medical Writing to enhance efficiency, quality, and scalability of deliverables
• Driving process improvement activities, medical writing competency development, and skill building across the Safety Medical Writing function
• Acting as an expert resource for junior team members, sharing knowledge and taking proactive steps to raise the bar for the team
Your new department
Safety Medical Writing is a global team within Global Patient Safety, situated in Bangalore, India and Søborg, 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.
Global Patient Safety is an organization of more than 400 highly professional people with a high level of education within Life Sciences. Safety Medical Writing is responsible for reporting on the emerging safety profile based on routine surveillance of all Novo Nordisk’s products (both currently marketed and under development worldwide), to ensure patient safety.
Candidate Profile
We're looking for a Senior Safety Medical Writer who combines deep pharmacovigilance expertise with a genuine passion for clear, precise scientific communication. You'll bring with you :
• A master's degree and/or PhD in Life Sciences (e.g. Pharmacy, Medicine, Veterinary, or Biological Sciences), combined with more than 7 years of experience working within pharmacovigilance and medical writing
• Expert understanding of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and RMPs, including the guidelines and regulations that drive their preparation
• Excellent analytical and communication skills, with fluency in written and spoken English and a flair for scientific communication and data presentation
• Experience in applying artificial intelligence, structured authoring, or other technical solutions in medical writing
• A highly collaborative approach, with the ability to lead cross-functional team members, negotiate solutions, and advise on document structure and content
• The ability to manage multiple projects simultaneously and deliver high-quality documents on schedule
• Experience handling documents of high complexity, such as Marketing Authorisation Application submissions, is considered an advantage
Additional Information
Experience : 7 years
Qualification : master's degree and/or PhD in Life Sciences
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Reg Affairs & Safety Pharmacovigilance
End Date : 27 September 2026
Sr Safety Medical Writer : Apply Online
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