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Senior Safety Medical Writer

Novo Nordisk
7+ years
Not Disclosed
Bangalore, India
1 May 20, 2026
Job Description
Job Type: Full Time Education: Ph.D/M.S Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Senior Safety Medical Writer

Company: Novo Nordisk
Department: Safety Medical Writing, Safety Surveillance, Global Patient Safety
Category: Regulatory Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, India
Work Location: Novo Nordisk Global Business Services (GBS), Bangalore, India


Job Overview

Novo Nordisk is seeking an experienced Senior Safety Medical Writer to join the Global Patient Safety team. This role is ideal for professionals passionate about patient safety, scientific writing, and pharmacovigilance compliance. The selected candidate will independently manage complex safety reporting assignments, ensuring regulatory accuracy, scientific clarity, and timely delivery of high-quality pharmacovigilance documentation.

This is a senior-level role requiring deep expertise in aggregate safety analysis, regulatory medical writing, and cross-functional collaboration within a global pharmaceutical environment.


Key Responsibilities

As a Senior Safety Medical Writer, you will:

  • Prepare complex aggregate safety reports, including pharmacovigilance regulatory documentation.
  • Develop and maintain Risk Management Plans (RMPs) and responses to Health Authority queries.
  • Author high-quality safety surveillance documents ensuring scientific accuracy, compliance, and clarity.
  • Collaborate with cross-functional global teams to ensure timely and accurate safety data reporting.
  • Evaluate and implement updates in local and global pharmacovigilance regulations and guidelines.
  • Support innovation initiatives and technical optimization projects to improve efficiency, scalability, and quality of medical writing deliverables.
  • Drive process improvement activities within Safety Medical Writing operations.
  • Contribute to capability building, competency development, and skill enhancement across the medical writing team.
  • Provide subject matter expertise, mentorship, and guidance to junior team members.
  • Handle multiple high-complexity writing projects while maintaining strict deadlines and quality standards.
  • Support documentation related to emerging safety profiles of marketed and pipeline pharmaceutical products.

Required Qualifications

Candidates should meet the following requirements:

  • Master’s Degree and/or PhD in Life Sciences, including:
    • Pharmacy
    • Medicine
    • Veterinary Sciences
    • Biological Sciences
    • Related healthcare disciplines
  • Minimum 7+ years of experience in:
    • Pharmacovigilance
    • Safety medical writing
    • Regulatory safety documentation
  • Strong understanding of:
    • Pharmacovigilance principles
    • Drug development lifecycle
    • Global regulatory compliance requirements
  • Expert-level knowledge of:
    • Periodic Safety Update Reports (PSURs)
    • Development Safety Update Reports (DSURs)
    • Risk Management Plans (RMPs)
    • Pharmacovigilance regulatory guidelines
  • Excellent analytical, communication, and scientific writing skills.
  • Strong ability to present safety data clearly and professionally.
  • Experience handling complex regulatory documentation and submissions.
  • Ability to manage multiple concurrent projects effectively.
  • Strong collaboration and stakeholder management capabilities.
  • Fluent written and spoken English (business communication level).

Preferred Qualifications

The following will be considered an advantage:

  • Experience with Artificial Intelligence (AI) applications in medical writing.
  • Knowledge of structured authoring tools or other technical writing automation solutions.
  • Experience handling high-complexity regulatory submissions, including:
    • Marketing Authorisation Applications (MAA)
    • Global regulatory submission documentation
  • Experience leading cross-functional teams and advising stakeholders on scientific content and document structure.