Job Title: Senior Safety Writer
Company: Fortrea
Location: Mumbai, India
Department: Clinical Safety / Pharmacovigilance
Job Type: Full-Time
Job ID: 26241
Experience Required: Minimum 4 Years in the Pharmaceutical Industry (including at least 3 Years of Medical or Safety Writing Experience)
About Fortrea
Fortrea is a leading global contract research organization (CRO) providing clinical development, pharmacovigilance, regulatory, and data management services to pharmaceutical, biotechnology, and medical device companies worldwide. With extensive expertise in clinical safety and regulatory documentation, Fortrea supports sponsors throughout the drug development lifecycle while ensuring compliance with global regulatory standards and patient safety requirements.
Role Overview
The Senior Safety Writer plays a critical role in the preparation and management of complex pharmacovigilance and regulatory safety documents. This role is responsible for leading the authoring and review of aggregate safety reports, benefit-risk evaluations, risk management documentation, and signal detection reports required for global regulatory submissions.
The position requires strong expertise in medical writing, pharmacovigilance regulations, and safety data interpretation. In addition to technical writing responsibilities, the Senior Safety Writer mentors junior writers, coordinates writing activities across teams, and ensures timely delivery of high-quality regulatory documents for sponsors and internal stakeholders.
Key Responsibilities
Aggregate Safety Report Writing
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 other pharmacovigilance reports as required.
Risk Management and Safety Evaluation
Develop and review Risk Management Plans (RMPs) and benefit-risk evaluation reports.
Prepare safety documentation for pharmaceutical products and medical devices in accordance with regulatory requirements.
Regulatory and Technical Documentation
Author sections of the Common Technical Document (CTD), including Clinical Overviews, Clinical Summaries, and Non-Clinical Summaries.
Draft responses to questions or feedback from regulatory authorities and coordinate with cross-functional teams to ensure timely responses.
Prepare and update product labeling documents including 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 with internal teams and clients.
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 Communications
Prepare and review scientific manuscripts, conference abstracts, and posters for medical conferences.
Develop medical information responses for healthcare professionals when required.
Training and Mentorship
Provide coaching and training to junior medical writers and safety associates.
Develop training programs and offer shadowing opportunities to support team development.
Project Coordination and Quality Assurance
Manage the full lifecycle of safety reports including planning, drafting, review, approval, and submission.
Coordinate writing activities across multiple projects or teams when required.
Perform quality checks on safety documentation to ensure accuracy and regulatory compliance.
Maintain project metrics and support internal reporting and documentation activities.
Cross-Functional Collaboration
Collaborate with pharmacovigilance teams, safety physicians, regulatory affairs professionals, and clinical teams to gather necessary safety data.
Communicate effectively with internal teams and external clients to ensure project deliverables meet timelines and quality standards.
Educational Qualifications
Bachelor’s degree in Life Sciences or a related scientific discipline.
Advanced degree such as a 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 global safety reporting requirements.
Knowledge of ICH guidelines, Good Pharmacovigilance Practices (GVP), and ICH-GCP standards.
Excellent scientific writing, editing, and documentation skills.
Strong organizational and time management abilities.
Excellent communication and interpersonal skills.
Technical Skills
Proficiency in Microsoft Office tools including Word, Excel, and PowerPoint.
Experience working with pharmacovigilance databases and regulatory documentation systems is preferred.
Work Environment
This role operates in a professional office environment and may require travel of up to 10 percent depending on project needs, including occasional overnight stays.
Job Location
Mumbai, India.
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