Senior Safety Medical Writer

Novo Nordisk India Pvt Ltd; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Novo Nordisk Global Business Services (GBS) in Bengaluru, India seeks a Senior Safety Medical Writer to independently deliver complex pharmacovigilance writing tasks, ensuring accuracy, compliance, and clarity across global products.

You will prepare aggregate safety reports, RMPs, and regulatory responses, collaborating with cross-functional teams to maintain timely, high-quality documentation while aligning with local and global guidelines.

Qualifications

• Master's degree and/or PhD in Life Sciences with 7+ years in pharmacovigilance and medical writing.
• Expert understanding of PSURs, DSURs, and RMPs.
• Excellent analytical and communication skills in English.
• Experience applying AI or structured authoring in medical writing.
• Collaborative, able to lead cross-functional teams and advise on document structure.
• Manage multiple projects and deliver high-quality documents on schedule.
• Experience with high-complexity documents like MAAs is a plus.

Responsibilities

• Prepare complex aggregate safety reports, RMPs, and responses to Health Authority questions.
• Collaborate with cross-functional teams for high-quality scientific writing and timely safety reporting.
• Evaluate and implement changes to local/global guidelines for compliance.
• Contribute to innovation and technical optimisation in Safety Medical Writing.
• Drive process improvement and develop medical writing competencies.
• Act as expert resource for junior team members and raise team standards.

Skills

Analytical thinking

Communication skills

English fluency

AI in medical writing

Education

Master's or PhD in Life Sciences

Job description

Sr Safety Medical Writer Company: Novo Nordisk Global Business Services (GBS)

Shape the safety narrative behind medicines that reach millions of patients worldwide. In this role, your words don't just inform — they protect.

Your new role

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.

Your skills & qualifications

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.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline

27 September 2026. Applications are reviewed on an ongoing basis. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Experience Level

Senior Level