Safety Writer

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

Qualification:
• Bachelor’s degree in Life Sciences or related field
• Advanced degree (M.Sc., M.Pharm, PhD) preferred

Experience:
• Minimum 3 years of pharmaceutical industry experience
• At least 2 years of experience in medical or safety writing preferred
• Experience in regulatory submissions and pharmacovigilance documentation preferred

Skills:
• Strong knowledge of aggregate safety reporting and regulatory documentation
• Understanding of pharmacovigilance practices, ICH-GCP guidelines, and global regulatory requirements
• Excellent scientific writing, editing, and literature review skills
• Proficiency in MS Office and document management systems
• Strong organizational, communication, and time management skills
• Ability to work collaboratively in global cross-functional teams

About the Organization:
Fortrea is a global contract research organization providing clinical development, patient access, and pharmacovigilance solutions to pharmaceutical, biotechnology, and medical device companies. The organization focuses on delivering high-quality clinical and regulatory support to accelerate the development of life-saving therapies worldwide.