Safety Writer
Company: Fortrea
Job Title: Safety Writer
Location: Mumbai, India
Employment Type: Full-Time
Job Requisition ID: 262799
Application Deadline: June 11, 2026
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) providing clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device companies worldwide. The organization partners with global sponsors to support drug development through scientific expertise, regulatory excellence, pharmacovigilance, and clinical research services.
Position Summary
The Safety Writer is responsible for authoring, reviewing, and managing a wide range of aggregate safety reports, risk management documents, signal detection reports, and regulatory safety submissions for global pharmaceutical and biotechnology clients.
The role involves collaborating with cross-functional teams, conducting scientific literature reviews, supporting pharmacovigilance activities, and ensuring high-quality regulatory documentation that complies with global health authority requirements and industry standards.
This position requires strong scientific writing skills, excellent communication abilities, and a solid understanding of pharmacovigilance regulations, drug safety reporting, and regulatory submission processes.
Key Responsibilities
Aggregate Safety Report Writing
Author, review, and manage regulatory safety documents including:
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Annual Reports (IND and other regulatory submissions)
Risk Management Plans (RMPs)
Aggregate Safety Reports
Safety Surveillance Reports
Signal Detection Reports
Safety Issue Analysis Reports
Ensure all reports are scientifically accurate, regulatory compliant, and submitted within required timelines.
Medical & Regulatory Writing
Prepare Common Technical Document (CTD) sections and summaries.
Author:
Clinical Overviews
Clinical Summaries
Non-Clinical Overviews
Non-Clinical Summaries
Develop benefit-risk evaluation reports and supporting regulatory documentation.
Draft safety narratives for:
Serious Adverse Events (SAEs)
Adverse Drug Reactions (ADRs)
Special safety cases
Contribute to regulatory submission packages and safety dossiers.
Signal Detection & Risk Management
Author and review:
Signal evaluation reports
Signal management documents
Benefit-risk assessments
Safety trend analyses
Support routine and ad hoc signal detection activities.
Assist in identifying emerging safety concerns and potential risks.
Labeling & Product Safety Documentation
Support preparation, review, and maintenance of:
Core Data Sheets (CDS)
United States Prescribing Information (USPI)
Summary of Product Characteristics (SmPC/SPC)
Medication Guides (Med Guides)
Product labeling updates
Safety-related labeling documentation
Literature Review & Scientific Research
Conduct systematic literature searches for:
Aggregate safety reports
Signal evaluations
Risk management activities
Routine surveillance programs
Review scientific publications and safety-related literature.
Assess literature relevance and quality.
Prepare:
Literature summaries
Scientific abstracts
Safety assessments
Company commentary and recommendations
Report Planning & Project Management
Participate in project planning activities.
Lead report kick-off meetings and review discussions.
Coordinate with internal stakeholders and clients to obtain required data and inputs.
Track project timelines and ensure on-time delivery of assigned deliverables.
Manage report workflows and document review cycles.
Quality Review & Mentorship
Perform quality review of reports prepared by junior and associate medical writers.
Ensure consistency, scientific accuracy, and regulatory compliance across deliverables.
Provide guidance and support to junior team members when required.
Contribute to process improvements and quality initiatives.
Client & Stakeholder Management
Serve as a key point of contact for assigned projects.
Collaborate with:
Pharmacovigilance Teams
Regulatory Affairs Teams
Medical Reviewers
Safety Scientists
Clinical Development Teams
Sponsors and Clients
Facilitate effective communication throughout report development and submission processes.
Educational Qualifications
Required
Bachelor's Degree in:
Life Sciences
Pharmacy (B.Pharm)
Biotechnology
Biological Sciences
Medical Sciences
Other related healthcare disciplines
Equivalent relevant experience may be considered in lieu of educational qualifications.
Preferred
Master's Degree (M.Sc., M.Pharm, MBA Healthcare, Clinical Research, or related discipline)
PhD or advanced scientific degree
Experience Requirements
Required
Minimum 3 years of experience in the pharmaceutical, biotechnology, CRO, or healthcare industry.
OR
Minimum 2 years of experience specifically in:
Medical Writing
Safety Writing
Pharmacovigilance Writing
Regulatory Writing
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