Safety Surveillance Medical Writing Specialist
Category: Regulatory Affairs & Pharmacovigilance
Function: Safety Medical Writing – Safety Surveillance, Global Patient Safety
Location: Bangalore, Karnataka, India
Employment Type: Full-time
Work Location: On-site
Organization: Novo Nordisk Global Business Services (GBS)
Application Deadline: 31 January 2026
Role Overview
The Safety Surveillance Medical Writing Specialist plays a critical role within Global Patient Safety, responsible for delivering high-complexity regulatory pharmacovigilance documents that ensure patient safety and regulatory compliance across global markets. This role is ideal for experienced pharmacovigilance professionals with deep expertise in aggregate safety reporting, risk management documentation, and health authority interactions.
As a subject matter expert, you will contribute to scientific excellence, process innovation, and capability building within Safety Medical Writing while supporting Novo Nordisk’s mission to deliver safe and effective therapies worldwide.
Key Responsibilities
Safety Medical Writing & Regulatory Documentation
Author and manage complex aggregate safety reports, including:
Periodic Safety Update Reports (PSURs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Prepare scientifically robust responses to Health Authority questions related to safety surveillance.
Ensure accuracy, clarity, consistency, and regulatory compliance of safety documents aligned with global and local guidelines.
Cross-Functional Collaboration & Compliance
Collaborate with cross-functional stakeholders across Pharmacovigilance, Regulatory Affairs, Clinical Development, and Safety Surveillance teams.
Monitor, interpret, and implement updates to global and local pharmacovigilance regulations and guidelines.
Ensure timely and compliant submission of safety documentation to regulatory authorities.
Innovation, Process Excellence & Capability Building
Contribute to innovation and technical optimization initiatives, including structured authoring, AI-enabled tools, and automation in medical writing.
Drive continuous improvement activities to enhance quality, efficiency, and scalability of safety deliverables.
Support medical writing competency development through mentoring, training, and knowledge sharing.
Act as a subject matter expert and provide guidance to junior medical writers on document strategy, structure, and content.
Qualifications & Experience
Educational Qualification:
Master’s degree or PhD in Life Sciences (Pharmacy, Medicine, Veterinary Sciences, Biological Sciences, or related disciplines)
Experience Required:
Minimum 8+ years of proven experience in pharmacovigilance and safety medical writing
Demonstrated expertise in PSURs, DSURs, RMPs, and applicable global pharmacovigilance regulations
Experience handling high-complexity regulatory submissions, including Marketing Authorization Applications (MAA), is highly desirable
Technical & Professional Skills
Expert knowledge of pharmacovigilance processes and drug development lifecycle
Strong understanding of global safety regulations and reporting standards
Experience applying AI tools, structured authoring systems, or digital solutions in medical writing
Excellent analytical, problem-solving, and decision-making skills
Ability to manage multiple projects simultaneously and deliver high-quality outputs within deadlines
Strong leadership, collaboration, and stakeholder management capabilities
Exceptional written and verbal communication skills in business-level English
High proficiency in scientific data interpretation, presentation, and storytelling
About the Department
Safety Medical Writing is a global function within Global Patient Safety, with teams based in Bangalore, India and Søborg, Denmark. The department delivers high-quality regulatory pharmacovigilance documentation, ensuring safety data is communicated transparently, ethically, and in compliance with global regulatory expectations.
Why Join Novo Nordisk
Novo Nordisk is a global healthcare leader with over 100 years of innovation focused on defeating serious chronic diseases. The organization fosters a culture of curiosity, accountability, inclusion, and long-term impact, offering professionals the opportunity to contribute to meaningful work that improves patient lives worldwide.
Equal Opportunity & Recruitment Integrity
Novo Nordisk is an equal opportunity employer and is committed to an inclusive recruitment process. No recruitment fees are charged at any stage. Applicants are advised to remain cautious of fraudulent job offers and only engage through official Novo Nordisk recruitment channels.
How to Apply
Interested candidates should apply online by submitting their updated CV through the official application portal.
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