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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: 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
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Department: Regulatory Affairs & Safety Pharmacovigilance / Safety Medical Writing / Global Patient Safety
Experience Required: 7+ Years


Job Overview

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

The selected candidate will independently lead high-complexity medical writing assignments involving pharmacovigilance regulatory documentation, safety analyses, health authority responses, and strategic documentation initiatives supporting global patient safety programs.

This role is best suited for professionals seeking leadership growth in drug safety, medical writing, pharmacovigilance strategy, regulatory affairs, and scientific communications.


Key Responsibilities

Safety Medical Writing

  • Independently prepare complex scientific and regulatory safety documents
  • Deliver high-quality pharmacovigilance writing assignments with accuracy, compliance, and scientific clarity
  • Support global safety documentation aligned with regulatory expectations and internal quality standards

Aggregate Safety Reporting
Lead development and preparation of key pharmacovigilance deliverables, including:

  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Risk Management Plans (RMPs)
  • Responses to health authority safety queries
  • Complex aggregate safety assessments

Cross-Functional Collaboration

  • Partner with global teams across pharmacovigilance, safety surveillance, regulatory affairs, clinical development, and medical functions
  • Provide scientific writing guidance to stakeholders on content, structure, and compliance expectations
  • Ensure timely delivery of high-quality safety documentation

Regulatory Compliance

  • Monitor and implement updates in local and global pharmacovigilance regulations
  • Ensure documentation remains aligned with changing regulatory standards
  • Support compliance with internal SOPs and external pharmacovigilance requirements

Innovation & Technical Excellence

  • Support innovation initiatives within safety medical writing operations
  • Contribute to adoption of:
    • AI-enabled medical writing workflows
    • Structured authoring tools
    • Technical automation solutions
  • Improve efficiency, quality, and scalability of documentation processes

Process Improvement & Leadership

  • Contribute to continuous process improvement programs
  • Support competency development and capability building across medical writing teams
  • Mentor junior team members and share subject matter expertise
  • Support operational excellence and writing best practices

Required Qualifications

Educational Qualifications
Candidates should hold:

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

Relevant disciplines include:

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