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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: ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding

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

An exceptional senior-level opportunity is available for an experienced Senior Safety Medical Writer in the global pharmacovigilance and patient safety domain. This role is designed for highly accomplished professionals with extensive expertise in safety medical writing, aggregate safety reporting, pharmacovigilance regulatory documentation, risk management planning, and global safety surveillance operations.

The selected candidate will independently lead high-complexity scientific writing assignments, delivering regulatory-compliant pharmacovigilance documentation that supports global patient safety initiatives. This role requires advanced expertise in safety data interpretation, scientific communication, regulatory compliance, and cross-functional leadership.

This is an ideal opportunity for senior professionals seeking career advancement in drug safety, pharmacovigilance strategy, medical writing leadership, regulatory affairs, and global patient safety operations.


Key Responsibilities

Safety Medical Writing & Scientific Documentation

  • Independently prepare high-complexity pharmacovigilance and regulatory safety documents
  • Ensure scientific accuracy, regulatory compliance, consistency, and clarity across all deliverables
  • Translate complex safety data into structured, fit-for-purpose scientific documentation
  • Maintain high documentation quality aligned with global pharmacovigilance standards

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

  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Risk Management Plans (RMPs)
  • Health authority safety responses
  • Aggregate benefit-risk safety analyses
  • Complex regulatory pharmacovigilance documentation

Cross-Functional Collaboration

  • Partner with pharmacovigilance, safety surveillance, regulatory affairs, clinical development, and global medical teams
  • Provide expert scientific writing guidance on document strategy, structure, content, and compliance requirements
  • Collaborate with stakeholders to ensure timely completion of global safety deliverables

Regulatory Compliance & Governance

  • Evaluate updates to local and international pharmacovigilance guidelines
  • Support implementation of regulatory changes within medical writing processes
  • Ensure documentation remains compliant with global regulatory frameworks and internal SOPs

Innovation & Technical Transformation

  • Support innovation and digital transformation initiatives within safety medical writing
  • Contribute to implementation of:
    • AI-enabled medical writing solutions
    • Structured authoring platforms
    • Workflow automation tools
    • Technical optimization initiatives
  • Drive documentation scalability, quality improvement, and operational efficiency

Leadership & Capability Development

  • Mentor junior medical writers and provide subject matter expertise
  • Support competency development and knowledge-sharing initiatives
  • Contribute to medical writing excellence frameworks and process improvement programs
  • Act as an escalation expert for high-complexity documentation tasks

Required Qualifications

Educational Qualifications
Candidates must hold:

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