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Senior Safety Medical Writer

Novo Nordisk
Novo Nordisk
7+ years
preferred by company
Bangalore, India
1 May 14, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Senior Safety Medical Writer
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Department: Regulatory Affairs & Safety Pharmacovigilance / Safety Medical Writing / Global Patient Safety
Experience Required: 7+ Years
Application Deadline: 25 May 2026


Job Overview

A leading global opportunity is available for an experienced Senior Safety Medical Writer within the pharmacovigilance and global patient safety domain. This role is ideal for highly skilled professionals with extensive expertise in safety medical writing, pharmacovigilance documentation, aggregate safety reporting, regulatory submissions, risk management planning, and global safety compliance.

The selected candidate will independently manage complex safety writing deliverables, including regulatory pharmacovigilance documentation, aggregate safety analyses, and high-priority health authority responses. This role requires deep scientific expertise, regulatory writing excellence, and the ability to collaborate across global cross-functional teams.

This position is highly suitable for senior professionals seeking growth in drug safety, medical writing leadership, pharmacovigilance strategy, global regulatory affairs, and safety surveillance operations.


Key Responsibilities

Safety Medical Writing & Regulatory Documentation

  • Independently prepare complex pharmacovigilance regulatory documents with high scientific accuracy and compliance
  • Develop aggregate safety reports and structured regulatory safety documentation
  • Ensure clear, compliant, and high-quality presentation of clinical and post-marketing safety data
  • Support high-priority global pharmacovigilance writing deliverables

Aggregate Safety Reporting
Lead preparation and review of complex aggregate safety documents, including:

  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Risk Management Plans (RMPs)
  • Health authority safety responses
  • High-complexity pharmacovigilance submissions

Cross-Functional Collaboration

  • Partner with global pharmacovigilance, regulatory affairs, safety surveillance, clinical, and medical teams
  • Provide scientific writing guidance on document content, structure, and regulatory expectations
  • Collaborate with stakeholders to ensure timely and accurate safety submissions

Compliance & Regulatory Excellence

  • Monitor evolving local and global pharmacovigilance regulations
  • Support implementation of guideline updates and regulatory process changes
  • Ensure internal documentation aligns with global compliance and quality standards

Innovation & Process Improvement

  • Contribute to innovation initiatives within safety medical writing
  • Support adoption of AI-enabled medical writing tools, structured authoring solutions, and technical automation improvements
  • Drive process optimization to improve scalability, efficiency, and documentation quality

Mentorship & Leadership

  • Serve as a subject matter expert for junior team members
  • Support medical writing capability development and internal knowledge sharing
  • Contribute to training, competency building, and writing excellence initiatives
  • Help strengthen team-wide scientific communication standards

Required Qualifications

Educational Qualifications
Candidates should hold one of the following:

  • Master’s Degree in Life Sciences
  • PhD in Life Sciences

Relevant academic disciplines include:

  • Pharmacy
  • Medicine
  • Veterinary Sciences
  • Biological Sciences
  • Clinical Research
  • Related healthcare or scientific disciplines