– Safety Writer
Location: Mumbai
Category: Clinical
Job ID: 2441263
Company: Fortrea
Company Overview
Fortrea is a global contract research organization (CRO) dedicated to scientific rigor and innovation in clinical research. With a presence in nearly 100 countries, we provide pharmaceutical, biotechnology, and medical device clients with industry-leading clinical development, patient access, and technology solutions.
Role Overview
The Safety Writer will be responsible for writing and reviewing global regulatory safety reports, literature reviews, and signal detection analyses. The role involves collaborating with internal teams and clients to ensure high-quality safety documentation for regulatory submissions.
Key Responsibilities
Regulatory Safety Writing & Documentation
Write and contribute to safety reports for global regulatory submissions, including:
Annual Reports (IND and others)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Take ownership of assigned deliverables, collaborating with internal and client stakeholders to gather required inputs.
Perform quality reviews of safety reports prepared by junior writers.
Author or contribute to benefit-risk evaluation reports, justification/supporting documents for label updates, and ad-hoc safety reports.
Write Common Technical Document (CTD) summaries, including Non-Clinical and Clinical Overviews and Clinical Summaries.
Prepare medical information responses for healthcare professionals (HCPs).
Safety Data Analysis & Signal Detection
Author/contribute to signal detection reports and safety issue analysis reports.
Write subject narratives for adverse drug reactions and serious adverse events.
Assist in labeling activities, including updates to Core Data Sheets, USPI, centralized SPCs, and Med Guides.
Perform literature searches for authoring safety reports and conducting routine surveillance activities.
Review and refine search strategies and assess relevant scientific articles.
Process Improvement & Compliance
Lead kick-off meetings and round-table discussions for comment resolution.
Implement and promote efficient, high-quality processes to meet regulatory timelines and deliverables.
Ensure compliance with regulatory requirements and standard operating procedures (SOPs).
Maintain a culture of high customer service and collaboration.
Required Qualifications & Experience
Education:
Bachelor’s/Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
Experience:
Minimum 3-6 years of experience in pharmacovigilance writing, medical writing, or regulatory safety documentation.
Strong understanding of pharmacovigilance regulations (FDA, EMA, ICH) and global safety reporting requirements.
Experience with safety databases, literature reviews, and signal detection processes.
Prior experience in authoring and reviewing global regulatory safety reports.
Skills & Competencies:
Excellent scientific writing skills with strong attention to detail.
Strong analytical and data interpretation abilities.
Effective communication and stakeholder management skills.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and safety database systems.
Ability to work independently and in cross-functional teams.
About Fortrea
Fortrea is committed to advancing clinical trials and patient access through cutting-edge scientific innovation. We provide a collaborative and inclusive work environment where professionals can make a meaningful impact on global healthcare.
Equal Opportunity Employer Statement
Fortrea is an Equal Opportunity Employer (EOE/AA) that fosters diversity and inclusion. We do not discriminate based on race, religion, gender, disability, veteran status, or any other legally protected characteristic.
For more details, visit www.fortrea.com.
If you require accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.
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