Safety Medical Writing Specialist – Pharmacovigilance
Location: Bangalore, Karnataka, India
Team: Safety Medical Writing, Safety Surveillance, Global Patient Safety
Experience Required: 8+ years in Pharmacovigilance and Safety Medical Writing
Employment Type: Full-Time
About the Role
Novo Nordisk is seeking a highly experienced Safety Medical Writing Specialist to join our Global Patient Safety team in Bangalore. This role focuses on high-complexity safety surveillance reporting and preparation of regulatory pharmacovigilance documents to ensure clear, accurate, and compliant communication of safety data across the product lifecycle.
As a Safety Medical Writing Specialist, you will be a key contributor to global safety documentation, collaborating with cross-functional teams and ensuring adherence to evolving regulatory requirements.
Key Responsibilities
Prepare and review complex aggregate safety reports, Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and Development Safety Update Reports (DSURs).
Respond to Health Authority questions with high-quality scientific writing and accurate safety interpretations.
Collaborate with cross-functional teams to ensure timely and compliant submission of safety documents.
Monitor and implement changes in local and global regulatory guidelines to maintain compliance and quality of outputs.
Lead process improvement initiatives to enhance efficiency, quality, and scalability within Safety Medical Writing.
Mentor and provide guidance to junior team members, promoting best practices in scientific writing and safety reporting.
Apply structured authoring, AI tools, or other technical solutions to optimize medical writing workflows.
Manage multiple projects simultaneously, delivering high-quality documentation within established timelines.
Required Qualifications
Master’s or PhD in Life Sciences (Pharmacy, Medicine, Veterinary, Biological Sciences)
Minimum 8 years of experience in pharmacovigilance and safety medical writing
In-depth knowledge of PSURs, DSURs, RMPs, and global pharmacovigilance regulations
Strong analytical, scientific, and written communication skills
Proven ability to handle complex regulatory documents, including Marketing Authorization Applications
Experience with AI-assisted medical writing, structured authoring, or other technical documentation tools
Strong collaboration and leadership skills in cross-functional global teams
Fluency in written and spoken English, with a flair for scientific communication and data presentation
About the Team
The Safety Medical Writing team within Global Patient Safety is based in Bangalore, India, and Søborg, Denmark. The team ensures the accuracy, transparency, and regulatory compliance of safety documents across the product lifecycle. Safety Medical Writing plays a pivotal role in ensuring patient safety while supporting Novo Nordisk’s global regulatory obligations.
Why Novo Nordisk
At Novo Nordisk, we are dedicated to defeating serious chronic diseases and creating long-term health impact. With over 100 years of innovation and a culture of curiosity, collaboration, and inclusivity, we provide employees with opportunities to grow, learn, and contribute to life-changing healthcare solutions globally.
Work in a dynamic, science-driven, and collaborative environment
Engage in cutting-edge pharmacovigilance and regulatory activities
Contribute to global patient safety and benefit-risk assessment strategies
Be part of a legacy of impact reaching millions of patients worldwide
Equal Opportunity
Novo Nordisk is an inclusive employer, committed to equality of opportunity and diversity in recruitment. All employment decisions are based on qualifications, skills, and merit. We ensure accessibility and reasonable accommodations for individuals with disabilities and respect for religious practices.
Application Deadline: 31st January 2026
How to Apply: Submit your CV online via the Novo Nordisk career portal.
SEO & Global Keywords Optimized: Safety Medical Writing Jobs India, Pharmacovigilance Medical Writer, PSUR DSUR RMP Specialist, Global Patient Safety Careers, Regulatory Pharmacovigilance Jobs, Bangalore Pharma Jobs, Safety Surveillance Specialist
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