Fortrea is a leading global contract research organization (CRO) committed to delivering high-quality clinical trial solutions to pharmaceutical, biotechnology, and medical device companies. With a focus on innovation, compliance, and patient safety, Fortrea provides comprehensive drug development services, including pharmacovigilance, regulatory submissions, and risk management.
Join a dynamic team where expertise meets excellence, and contribute to shaping the future of drug safety and regulatory compliance.
Job Description
Job Overview
Fortrea is seeking a Safety Writing Assistant II to support the preparation and review of aggregate safety reports, risk management documents, and signal detection activities. The role involves collaborating with medical writers, preparing data summaries, and ensuring timely delivery of high-quality regulatory documents.
Key Responsibilities
- Assist in authoring sections of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and other regulatory documents.
- Support signal detection activities, including data cleaning, literature reviews, and preparing signal reports.
- Prepare case narratives, data summaries, and line listings for safety reports.
- Conduct literature searches and summarize relevant articles for inclusion in reports.
- Ensure compliance with ICH-GCP, pharmacovigilance regulations, and company SOPs.
- Collaborate with cross-functional teams to resolve comments and finalize report content.
- Maintain high-quality documentation and adhere to project timelines.
Qualifications & Experience
Minimum Requirements:
- Bachelor’s degree in Life Sciences or related field.
- 6 months to 1 year of experience in the pharmaceutical industry.
- Strong written and verbal English communication skills.
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Basic understanding of pharmacovigilance, regulatory guidelines, and ICH-GCP.
Preferred Qualifications:
- Master’s or PhD in Life Sciences or related discipline.
- Experience in medical writing, pharmacovigilance, or regulatory affairs.
- Familiarity with safety databases and literature review tools.
Work Environment & Physical Demands
- Hybrid work model (office + remote).
- 5% travel may be required.
