Safety Writing Associate II

Roles & Responsibilities
• Assist in preparation and review of aggregate safety reports, risk management plans, and signal detection activities
• Generate outputs and reports from safety databases and systems
• Support data requests, sales data calculations, regulatory website searches, and report planning activities
• Author full or partial sections of global regulatory safety documents, including: Annual Reports (IND and others), PSUR / PADER / PBRER, DSUR, Risk Management Plans (RMPs)
• Develop assigned report sections using templates, reused content, and low to medium complexity safety analyses
• Review and annotate line listings, prepare case narratives, and summarize safety data per approved strategies
• Participate in comment resolution and report finalization discussions
• Support signal detection activities, including data cleaning, line listing review, and preparation of signal review materials
• Assist in preparing ad hoc safety reports, safety issue analyses, and label update justifications
• Write sections of Common Technical Document (CTD) summaries, including Clinical and Non-Clinical Overviews
• Conduct literature searches and screen publications for relevance to safety reports
• Prepare literature abstracts and summaries for regulatory documentation
• Ensure compliance with SOPs, regulatory requirements, GVP, and ICH-GCP guidelines
• Promote consistent, efficient, and high-quality writing processes to meet project timelines
• Maintain high standards of customer service and effective collaboration with internal and external stakeholders

Qualification
• Bachelor’s degree in Life Sciences or equivalent
• Advanced degree (Master’s or PhD) preferred

Experience
• Excellent written and spoken English skills
• Strong organizational and time management abilities
• Scientific or clinical research experience is desirable
• Knowledge of pharmacovigilance, regulatory requirements, and ICH-GCP guidelines preferred
• Around 2 years of experience in medical writing or the pharmaceutical industry is an advantage

Skills
• Proficiency in MS Word, PowerPoint, and Excel
• Strong analytical and documentation skills
• Ability to manage multiple deliverables under timelines
• Excellent interpersonal and communication skills

About the Company
Fortrea is a leading global clinical research organization providing end-to-end clinical development and safety solutions, supporting pharmaceutical and biotechnology companies worldwide.