Job Title: Senior Safety Writer
Company: Fortrea
Location: Mumbai, India
Job Type: Full-Time
Category: Clinical / Pharmacovigilance
Job ID: 26241
Experience Required: Minimum 4 Years in Pharmaceutical Industry (including at least 3 Years in Medical Writing)
About Fortrea
Fortrea is a leading global contract research organization (CRO) specializing in clinical development, pharmacovigilance, and regulatory services for pharmaceutical, biotechnology, and medical device companies. With extensive scientific expertise and advanced clinical research capabilities, Fortrea supports sponsors throughout the drug development lifecycle, helping bring innovative and safe therapies to patients worldwide.
Role Overview
Fortrea is seeking an experienced Senior Safety Writer to lead the preparation, review, and management of regulatory safety reports and medical writing deliverables. This role involves authoring aggregate safety reports, risk management documentation, and signal detection reports while ensuring regulatory compliance and scientific accuracy. The selected candidate will oversee end-to-end safety document development, mentor junior medical writers, and collaborate with cross-functional teams to deliver high-quality regulatory documentation within defined timelines.
Key Responsibilities
Aggregate Safety Report Writing
Author and review aggregate safety reports for global regulatory submissions, including Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Experience Reports (PADER), Periodic Benefit-Risk Evaluation Reports (PBRER), Development Safety Update Reports (DSUR), and Annual Reports.
Prepare Additional Clinical Overviews (ACO) and addendum safety reports as required by project scope.
Ensure scientific accuracy, regulatory compliance, and consistency across safety documentation.
Risk Management and Benefit–Risk Evaluation
Author and review Risk Management Plans (RMPs), benefit-risk evaluation reports, and other safety risk management documentation.
Contribute to benefit-risk assessments and ensure alignment with regulatory safety requirements.
Signal Detection and Safety Analysis
Participate in signal detection activities and safety review meetings.
Conduct literature searches and analyze safety data from pharmacovigilance databases and published scientific sources.
Author signal evaluation reports, safety issue analysis reports, and ad-hoc safety documentation.
Regulatory and Scientific Documentation
Prepare sections of the Common Technical Document (CTD), including Clinical Overviews, Clinical Summaries, and Non-Clinical Summaries.
Draft responses to health authority queries and support regulatory interactions.
Create and update labeling documents such as Core Data Sheets (CDS), United States Prescribing Information (USPI), Summary of Product Characteristics (SmPC), and Medication Guides.
Medical Writing and Scientific Communication
Author and review scientific manuscripts, abstracts, and conference posters.
Prepare medical information responses for healthcare professionals when required.
Team Leadership and Training
Mentor junior medical writers and provide coaching, training sessions, and hands-on development opportunities.
Act as a writing coach to improve team capabilities and maintain high-quality documentation standards.
Coordinate writing activities across multiple writers when managing large safety reporting projects.
Project Management and Quality Assurance
Manage end-to-end report development including planning, drafting, review, approval, and submission processes.
Track project deliverables, timelines, and quality metrics.
Perform quality control checks and ensure adherence to SOPs and regulatory guidelines.
Support project resource estimation and proposal development when required.
Cross-Functional Collaboration
Collaborate with safety physicians, regulatory teams, pharmacovigilance professionals, and clinical teams to collect and analyze safety data.
Coordinate with internal stakeholders and external clients to obtain inputs and resolve issues affecting project deliverables.
Educational Qualifications
Bachelor’s degree in Life Sciences or a related scientific discipline.
Advanced degree such as Master’s or PhD in Life Sciences, Pharmacy, or related field is preferred.
Experience Requirements
Minimum 4 years of experience in the pharmaceutical or life sciences industry.
At least 3 years of experience in medical writing or safety writing roles.
Experience with pharmacovigilance safety reports and regulatory documentation.
Required Skills and Competencies
Strong knowledge of pharmacovigilance regulations and safety reporting requirements.
Good understanding of ICH guidelines, Good Pharmacovigilance Practices (GVP), and ICH-GCP standards.
Excellent scientific writing and editing skills.
Strong attention to detail and documentation accuracy.
Proficiency in Microsoft Office tools including Word, Excel, and PowerPoint.
Excellent communication, collaboration, and interpersonal skills.
Strong organizational and time management abilities.
Preferred Skills
Experience in clinical research or pharmacovigilance environments.
Expertise in signal detection, benefit-risk assessment, and regulatory safety reporting.
Work Environment and Travel Requirements
The role may require travel up to 10 percent of the time depending on project requirements, including occasional overnight stays.
Job Location
Mumbai, India.
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