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Sr Safety Medical Writer

Novo Nordisk
Novo Nordisk
7+ years
preferred by company
Bangalore, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. 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, ICD-10 CM, CPT, HCPCS Coding

Sr Safety Medical Writer

Location: Bengaluru, Karnataka, India
Company: Novo Nordisk Global Business Services (GBS)
Job Type: Full-Time
Work Mode: Onsite / Hybrid (As Per Business Requirement)
Industry: Pharmacovigilance | Drug Safety | Regulatory Affairs | Medical Writing | Life Sciences
Department: Safety Medical Writing | Safety Surveillance | Global Patient Safety
Experience Required: 7+ Years (Freshers Not Eligible)
Qualification Required: Master’s Degree / PhD in Life Sciences
Application Deadline: 25 May 2026

Job Overview

Novo Nordisk is hiring an experienced Sr Safety Medical Writer for its Global Patient Safety team in Bengaluru. This senior-level opportunity is ideal for highly experienced pharmacovigilance professionals with deep expertise in aggregate safety reporting, safety medical writing, risk management plans (RMP), regulatory pharmacovigilance documentation, benefit-risk analysis, and global drug safety compliance.

The selected candidate will independently manage complex pharmacovigilance writing deliverables, collaborate with global cross-functional stakeholders, and contribute to innovation, process excellence, and scientific quality within the safety medical writing function.

This role is ideal for professionals seeking leadership growth in drug safety medical writing, regulatory pharmacovigilance, aggregate safety reporting, and global patient safety operations.

Job Responsibilities

Aggregate Safety Reporting

Lead preparation and review of complex global pharmacovigilance documents including:

  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Risk Management Plans (RMPs)
  • Aggregate Safety Reports
  • Health Authority response documents
  • Safety benefit-risk documentation

Ensure scientific accuracy, regulatory compliance, and timely submission of all deliverables.

Regulatory Safety Medical Writing

  • Independently develop high-complexity pharmacovigilance regulatory documentation.
  • Prepare scientifically robust safety narratives, analyses, and regulatory safety content.
  • Support global pharmacovigilance reporting aligned with internal and external compliance standards.

Cross-Functional Collaboration

  • Partner with:
    • Global Patient Safety teams
    • Pharmacovigilance stakeholders
    • Medical reviewers
    • Regulatory affairs teams
    • Clinical development teams
    • Cross-functional business partners
  • Drive alignment for safety reporting deliverables and document quality.

Benefit-Risk & Safety Surveillance Support

  • Support evaluation of emerging product safety profiles.
  • Contribute to benefit-risk communication and safety surveillance reporting.
  • Ensure transparent, fit-for-purpose safety documentation.

Process Improvement & Innovation

  • Contribute to:
    • Medical writing process optimization
    • Quality improvement initiatives
    • Operational scalability projects
    • Technical transformation efforts
    • Innovation programs within safety medical writing
  • Support adoption of structured authoring, AI-enabled writing workflows, and advanced documentation tools.

Regulatory Compliance & Guideline Management

  • Monitor evolving:
    • Global pharmacovigilance regulations
    • Safety reporting guidelines
    • Internal compliance requirements
  • Implement process changes based on regulatory updates.

Team Mentorship & Capability Building

  • Act as a subject matter expert for junior safety medical writers.
  • Share best practices, technical knowledge, and process expertise.
  • Support competency development and team capability building.

Project & Delivery Management

  • Manage multiple complex safety writing projects simultaneously.
  • Ensure timely delivery of high-quality documentation under strict regulatory timelines.
  • Proactively identify risks, delays, and mitigation opportunities.

Advanced Regulatory Documentation Support

Preferred involvement in:

  • Marketing Authorization Application (MAA) documentation
  • High-complexity regulatory submissions
  • Advanced global safety documentation projects

About the Department

Safety Medical Writing is a global function within Novo Nordisk’s Global Patient Safety organization, operating across Bengaluru and Søborg, Denmark.

The team specializes in high-quality regulatory pharmacovigilance documentation supporting both marketed and development-stage pharmaceutical products globally. The broader Global Patient Safety organization includes 400+ life sciences professionals focused on patient safety, ethical scientific communication, and global pharmacovigilance excellence.

Educational Qualification

Candidates must have:

  • Master’s Degree in Life Sciences

Preferred backgrounds:

  • Pharmacy
  • Medicine
  • Veterinary Sciences
  • Biological Sciences
  • Pharmacology
  • Biomedical Sciences

Highly Preferred:

  • PhD in Life Sciences or related healthcare discipline