Fortrea is a globally recognized contract research organization (CRO) with a dedication to scientific rigor and extensive experience in clinical development. With operations spanning approximately 100 countries, Fortrea offers a comprehensive suite of clinical development, patient access, and technology solutions across over 20 therapeutic areas. The company is revolutionizing drug and device development, ensuring swift and efficient delivery of life-changing therapies to patients worldwide.
Job Overview
The role of Safety Writing Assistant II involves the preparation and review of aggregate safety, risk management, and signal detection reports. The position includes supporting medical writers with data collection, strategy execution, and content development, ensuring the timely delivery of high-quality safety documents for global regulatory submissions.
Responsibilities in Job
- Report Preparation and Review:
- Author parts of safety reports such as Annual Reports, Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
- Develop assigned report sections, review line listings, and prepare case narratives and data summaries.
- Participate in comment resolution and finalize report content.
- Signal Detection Support:
- Assist in data cleaning and review for signal detection activities.
- Prepare materials for signal review meetings and contribute to signal reports.
- Ad Hoc Reporting:
- Support preparation of safety issue analysis reports and documents for label updates.
- Literature Reviews:
- Conduct literature searches and prepare summaries or abstracts of selected articles.
- Regulatory Document Authoring:
- Write sections of Common Technical Document (CTD) summaries, including non-clinical and clinical overviews and summaries.
- Process Improvement:
- Promote consistent, efficient, and quality processes.
- Ensure compliance with regulatory requirements and good pharmacovigilance practices.
Qualifications
Minimum Requirements:
- A degree in life sciences or equivalent.
- At least 6 months to 1 year of experience in the pharmaceutical industry.
- Good understanding of regulatory requirements and ICH-GCP guidelines.
Preferred Qualifications:
- Advanced degree (e.g., PhD or Master’s) in life sciences.
Skills
- Communication:
- Excellent command of written and spoken English.
- Strong written and verbal communication skills.
- Technical Proficiency:
- Proficiency in MS Office.
- Organizational Abilities:
- Strong time management and organizational skills.
- Ability to work collaboratively and foster strong interpersonal relationships.
- Knowledge Base:
- Familiarity with good pharmacovigilance practices and clinical research.
