Job Title: Senior Safety Writer
Company: Fortrea
Location: Mumbai, India
Department: Clinical Safety / Pharmacovigilance
Job Type: Full-Time
Job ID: 2694
Experience Required: Minimum 4 Years in the Pharmaceutical Industry (including at least 3 Years in Medical or Safety Writing)
About Fortrea
Fortrea is a global contract research organization (CRO) dedicated to providing advanced clinical development, pharmacovigilance, and regulatory services to pharmaceutical, biotechnology, and medical device companies worldwide. With strong scientific expertise and innovative clinical research capabilities, Fortrea supports sponsors across the entire drug development lifecycle while ensuring regulatory compliance, patient safety, and high-quality data management.
Role Overview
The Senior Safety Writer is responsible for leading the preparation and review of complex pharmacovigilance and regulatory safety documents. This role involves managing the end-to-end lifecycle of aggregate safety reports, signal detection documentation, and benefit-risk evaluation reports for global regulatory submissions. The position requires strong expertise in pharmacovigilance writing, regulatory compliance, and safety data interpretation.
The Senior Safety Writer also plays an important mentoring role by supporting the training and development of junior medical writers while collaborating with cross-functional teams to ensure timely delivery of high-quality safety documentation to regulatory authorities and clients.
Key Responsibilities
Aggregate Safety Reporting
Author and review aggregate safety reports for global regulatory submissions including Annual Reports, Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Experience Reports (PADER), Periodic Benefit-Risk Evaluation Reports (PBRER), Development Safety Update Reports (DSUR), and addendum reports.
Prepare Additional Clinical Overviews (ACO) and related safety documentation for regulatory submissions.
Risk Management and Benefit–Risk Evaluation
Develop and review Risk Management Plans (RMPs) and benefit-risk evaluation reports.
Author medical device safety reports and other pharmacovigilance documentation as required.
Regulatory Documentation and Technical Writing
Write sections of Common Technical Documents (CTD) including Clinical Overviews, Clinical Summaries, and Non-Clinical Summaries.
Draft responses to regulatory authority questions and collaborate with stakeholders to manage regulatory feedback.
Support updates and revisions of product labeling documents such as Core Data Sheets (CDS), United States Prescribing Information (USPI), Summary of Product Characteristics (SmPC), and Medication Guides.
Signal Detection and Safety Analysis
Participate in signal detection activities and safety review meetings.
Conduct safety data analysis by reviewing pharmacovigilance databases, scientific literature, and external safety sources.
Author signal evaluation reports and safety issue analysis documentation.
Scientific Publications and Medical Communication
Prepare and review scientific manuscripts, conference abstracts, and posters.
Provide support in preparing medical information responses for healthcare professionals when required.
Training and Mentorship
Mentor junior medical writers and provide coaching, training programs, and shadowing opportunities.
Coordinate writing activities across teams for complex pharmacovigilance reporting projects.
Project Coordination and Quality Assurance
Manage report timelines including planning, drafting, review, approval, and submission stages.
Perform quality checks on safety documentation to ensure compliance with regulatory standards and internal procedures.
Track performance metrics and support continuous improvement initiatives.
Cross-Functional Collaboration
Work closely with pharmacovigilance teams, safety physicians, regulatory affairs professionals, and clinical teams to gather safety data and ensure accurate reporting.
Communicate effectively with internal stakeholders and external clients to ensure project deliverables are met within timelines.
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 fields 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, safety writing, or pharmacovigilance documentation.
Required Skills and Competencies
Strong understanding of pharmacovigilance regulations and safety reporting requirements.
Good knowledge of ICH guidelines, Good Pharmacovigilance Practices (GVP), and ICH-GCP standards.
Excellent scientific writing and editing skills.
Strong attention to detail and high standards of documentation accuracy.
Excellent communication and interpersonal skills.
Strong organizational and time management abilities.
Technical Skills
Proficiency in Microsoft Office tools including Word, Excel, and PowerPoint.
Experience working with pharmacovigilance safety databases and regulatory documentation systems.
Work Environment
This role operates within a collaborative office environment and may require occasional travel of up to 10 percent depending on project requirements.
Job Location
Mumbai, India.
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