Job Title: Principal Safety Writer
Location: Mumbai
Category: Clinical
Job ID: 2447515
Company Overview:
Fortrea is a global contract research organization (CRO) offering clinical development, patient access, and technology solutions across 20+ therapeutic areas, operating in ~100 countries. Their mission is to transform drug and device development for better patient outcomes.
Job Overview:
Lead the creation and review of aggregate safety reports, signal detection documentation, benefit-risk evaluations, and other safety-related regulatory documents. Serve as a technical expert guiding medical writing teams, coordinating client expectations, and maintaining high standards in deliverables.
Summary of Responsibilities:
Prepare and review safety reports for regulatory submission including:
Annual Reports, PSURs, PADERs, DSURs, Clinical Overviews, Medical Device Reports.
Lead full lifecycle of report production, ensuring quality and timeline compliance.
Coordinate with clients on expectations, challenges, and resolution of issues.
Author/review Risk Management Plans (RMPs), Benefit-Risk Evaluation Reports, and support labeling updates.
Participate in signal detection and author corresponding reports.
Attend client meetings for safety/benefit-risk reviews and recommend label updates or mitigation strategies.
Draft responses to regulatory feedback and collaborate on their management.
Create scientific content for abstracts, posters, and manuscripts.
Coach and mentor junior writers, provide training, and promote best practices.
Assist in project management: schedule tracking and compliance monitoring.
Contribute to business development by estimating resources and supporting RFPs.
Prepare and update product labels (e.g., Core Data Sheets, USPI, SPCs, Med Guides).
Conduct literature reviews and develop complex search strategies.
Promote process efficiency and regulatory compliance.
Uphold customer service excellence and complete other duties as required.
Minimum Qualifications:
Bachelor's degree in Life Sciences or equivalent.
Fortrea may consider equivalent experience in place of formal education.
Experience (Minimum Required):
5–7 years in the pharmaceutical industry, including at least 4 years in medical writing.
Strong English communication skills (written and spoken).
Proficiency in MS Office.
Strong organizational, leadership, and interpersonal skills.
Familiarity with regulatory requirements, pharmacovigilance practices, ICH GCP, and global submission standards.
Experience in clinical research or drug development.
Preferred Qualifications:
Advanced degree (PhD or Master’s).
Experience in drug discovery and pharmacovigilance.
Work Environment / Physical Demands:
Office-based or remote.
Available for up to 15% travel, including overnight as needed.
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