Safety Writer

Role & Responsibilities
• Prepare and review aggregate safety reports for global regulatory submissions including DSURs, PSURs, PADERs, RMPs, and Annual Reports
• Lead report planning activities such as data collection, kick-off meetings, timelines, and comment resolution
• Perform quality review of documents drafted by junior writers and provide constructive feedback
• Develop ad-hoc safety reports, benefit–risk evaluation documents, and label update justifications
• Write CTD summaries (clinical and non-clinical), clinical summaries, and regulatory documents
• Draft adverse event narratives and medical information responses for healthcare professionals
• Support signal detection activities and safety issue analysis reports
• Conduct literature searches, define review strategies, and summarize findings
• Collaborate with cross-functional teams and global clients to ensure timely, high-quality deliverables
• Ensure compliance with ICH-GCP, pharmacovigilance regulations, and global regulatory requirements

Qualification
• B.Pharm / M.Pharm / Pharm.D
• BSc / MSc (Life Sciences)
• PhD (preferred)

Experience
• Minimum 2–3+ years of relevant pharmaceutical industry experience
• At least 2 years of experience in medical writing or safety writing

Skills
• Strong expertise in pharmacovigilance and safety writing
• Excellent written and spoken English communication skills
• Knowledge of ICH guidelines, regulatory requirements, and PV practices
• Strong organizational, time-management, and quality-focused approach
• Proficiency in MS Office and regulatory documentation

About the Company
• Fortrea is a leading global CRO specializing in clinical development, pharmacovigilance, and regulatory services, Supports pharmaceutical, biotechnology, and medical device companies worldwide.