Sr Safety Medical Writer
Company: Novo Nordisk
Department: Safety Medical Writing, Safety Surveillance, Global Patient Safety
Location: Bangalore
Category: Regulatory Affairs & Safety Pharmacovigilance
Application Deadline: 25 May 2026
Job Summary
The Sr Safety Medical Writer is a senior-level scientific writing expert responsible for independently managing complex pharmacovigilance and aggregate safety reporting activities. The role focuses on preparing regulatory safety documents, supporting safety surveillance activities, driving process improvements, and collaborating across global teams to ensure high-quality, compliant, and timely safety reporting.
The position requires deep expertise in pharmacovigilance regulations, aggregate safety analyses, and medical writing practices.
Key Responsibilities
1. Aggregate Safety Reporting
Prepare complex pharmacovigilance and aggregate safety documents, including:
Periodic Safety Update Reports (PSURs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Responses to Health Authority questions
Ensure documents are:
Scientifically accurate
Regulatory compliant
Clear and concise
Delivered within timelines
2. Cross-functional Collaboration
Work closely with cross-functional teams to support:
Safety surveillance activities
Scientific data review
Timely safety reporting
Provide guidance on:
Document structure
Scientific content
Regulatory expectations
Collaborate with stakeholders to resolve issues and align on deliverables.
3. Regulatory Compliance & Guideline Implementation
Contribute to evaluation and implementation of:
Local pharmacovigilance guidelines
Global regulatory requirements
Internal compliance standards
Ensure safety documents remain aligned with evolving regulations and industry expectations.
4. Innovation & Process Optimization
Support innovation initiatives within Safety Medical Writing.
Contribute to:
Technical optimization projects
Structured authoring initiatives
AI-enabled medical writing solutions
Process scalability and efficiency improvements
Participate in continuous improvement activities across the department.
5. Team Support & Knowledge Sharing
Act as a subject matter expert (SME) for junior team members.
Support:
Skill development
Competency building
Knowledge sharing initiatives
Take proactive steps to improve team capability and operational excellence.
Required Qualifications
Educational Qualification
Master’s degree and/or PhD in Life Sciences, including:
Pharmacy
Medicine
Veterinary Sciences
Biological Sciences
Related disciplines
Experience
More than 7 years of experience in:
Pharmacovigilance
Safety medical writing
Regulatory safety documentation
Required Skills & Expertise
Pharmacovigilance & Regulatory Knowledge
Strong understanding of:
Drug development processes
Pharmacovigilance principles
Global safety regulations
Expert knowledge of:
PSURs
DSURs
RMPs
Relevant regulatory guidelines
Medical Writing & Scientific Communication
Strong scientific writing and data presentation skills.
Ability to:
Deliver high-quality documents independently
Handle complex safety reporting assignments
Manage multiple projects simultaneously
Fluency in:
Written English
Spoken English
Collaboration & Leadership
Highly collaborative and capable of:
Leading cross-functional discussions
Negotiating solutions
Advising stakeholders effectively
Ability to mentor and support junior writers.
Innovation & Technical Skills
Experience with:
Artificial intelligence applications in medical writing
Structured authoring tools
Technical writing optimization solutions
Ability to contribute to scalable documentation processes.
Preferred Qualifications
Experience handling highly complex regulatory documents, including:
Marketing Authorisation Application (MAA) submissions
Advanced regulatory safety submissions
About the Department
The Safety Medical Writing team is part of Global Patient Safety and operates across:
Bangalore
Søborg
The department focuses on:
Regulatory pharmacovigilance documentation
Safety surveillance reporting
Global product safety monitoring
Ethical and transparent communication of safety data
Global Patient Safety includes more than 400 professionals specializing in life sciences and patient safety operations worldwide.
Working at Novo Nordisk
Novo Nordisk is a global healthcare company dedicated to defeating chronic diseases through scientific innovation, long-term healthcare solutions, and patient-centered approaches.
The organization promotes:
Continuous learning
Collaboration
Innovation
Long-term career development
Inclusive and diverse work environments
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