Job Title: Principal Safety Writer – Pharmacovigilance & Regulatory Medical Writing
Location: Mumbai, Maharashtra, India
Job Category: Clinical / Drug Safety
Job ID: 26436
Company: Fortrea
Job Overview
Fortrea is seeking a Principal Safety Writer to lead the development, review, and lifecycle management of complex aggregate safety reports, risk management documentation, signal detection analyses, and benefit-risk evaluation reports for global regulatory submissions.
This is a senior-level leadership role requiring independent management of high-complexity safety deliverables, technical oversight of medical writing teams, and direct client engagement. The Principal Safety Writer will serve as a scientific and regulatory expert, ensuring high-quality documentation aligned with global pharmacovigilance standards and regulatory requirements across the US, EU, and emerging markets.
Key Responsibilities
Lead authoring and review of aggregate safety reports including:
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Development Safety Update Reports (DSURs)
Annual Reports (IND and other submissions)
Clinical Overviews and Medical Device Safety Reports
Author and review Risk Management Plans (RMPs), benefit-risk evaluation reports, ad hoc safety analyses, and documentation supporting labeling updates
Independently manage end-to-end report production, ensuring adherence to quality standards and regulatory timelines
Provide technical leadership and oversight to co-authors and writing teams; ensure accountability for team deliverables
Serve as primary client contact for safety writing projects; manage expectations, identify risks, and escalate issues when necessary
Lead or participate in signal detection and signal management processes, including literature review and database searches
Author signal evaluation reports and safety issue analysis reports
Participate in benefit-risk review meetings; collaborate with safety physicians to propose labeling changes and risk mitigation measures
Draft regulatory authority responses and coordinate cross-functional stakeholder input
Prepare abstracts, manuscripts, conference posters, and scientific publications
Develop medical information responses for healthcare professionals
Create and update labeling documents such as Core Data Sheets, USPI, Summary of Product Characteristics (SmPC), and Medication Guides
Conduct complex literature searches and execute structured search strategies
Mentor and coach junior writers; deliver training programs and promote adherence to style guides and writing standards
Support project management activities including schedule tracking, compliance metrics, and resource planning
Contribute to business development activities including RFP responses and resource estimation
Drive quality improvement initiatives and ensure compliance with SOPs and global regulatory frameworks
Educational Qualification
Bachelor’s degree in Life Sciences or equivalent
Advanced degree (Master’s or PhD) preferred
Experience Required
5–7 years of experience in the pharmaceutical industry
Minimum 4 years of medical writing experience, preferably in pharmacovigilance and aggregate safety reporting
Strong understanding of global pharmacovigilance regulations and ICH-GCP guidelines
Extensive knowledge of regulatory submission requirements across US, EU, and emerging markets
Comprehensive understanding of the pharmaceutical product development lifecycle
Experience in drug discovery and pharmacovigilance preferred
Demonstrated leadership, mentoring, and team management capabilities
Core Competencies
Excellent written and spoken English communication skills
Strong scientific writing and analytical expertise
Advanced knowledge of regulatory documentation standards
Ability to independently manage complex deliverables
Strong stakeholder engagement and client communication skills
Proficiency in MS Office and document management systems
Organizational excellence and time management proficiency
Work Environment & Travel
Office-based or remote work model
Up to 15% travel required, including overnight stays, depending on project needs
Why Join Fortrea?
Fortrea is a leading global CRO delivering clinical development and post-marketing safety solutions to pharmaceutical and biotechnology sponsors worldwide. The organization emphasizes regulatory excellence, scientific rigor, and patient safety across therapeutic areas.
This leadership role offers:
Strategic influence on global pharmacovigilance documentation
Direct client-facing responsibilities
Mentorship and technical leadership opportunities
Exposure to multinational regulatory environments
Career advancement within regulatory medical writing and safety science
Fortrea is an Equal Opportunity Employer committed to inclusive hiring and regulatory-compliant clinical operations.
This job posting is optimized for global search visibility in Principal Safety Writer, Pharmacovigilance Medical Writing Lead, Aggregate Safety Reporting, Risk Management Plans, Signal Detection, and Regulatory Safety Documentation careers across India and international markets on ThePharmaDaily.com.
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