– Safety Writing Assistant II
Location: Mumbai
Category: Clinical
Job ID: 2443859
Company: Fortrea
Company Overview
Fortrea is a global contract research organization (CRO) offering pharmaceutical, biotechnology, and medical device clients comprehensive clinical development, regulatory, and patient access solutions. Operating in nearly 100 countries, Fortrea is committed to advancing drug development and delivering life-changing therapies to patients worldwide.
Role Overview
The Safety Writing Assistant II will be responsible for supporting safety report preparation, performing database queries, and assisting in signal detection activities. This role involves authoring safety report sections, reviewing case narratives, and assisting medical writers in compiling regulatory safety documents.
Key Responsibilities
Safety Writing & Documentation
Assist in authoring parts of safety reports for global regulatory submissions, including:
Annual Reports (IND and others)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Other assigned regulatory safety documents
Develop assigned report sections using pre-populated templates, content re-use from other documents, and safety data analysis.
Review and annotate line listings, case narratives, and data summaries as per the approved strategy.
Participate in comment resolution discussions for assigned report sections.
Safety Data Management & Reporting
Perform database queries and generate reports from safety systems.
Conduct regulatory website searches and collate report planning materials.
Assist in distribution of data requests and sales data calculations for safety analysis.
Signal Detection & Analysis
Support medical writers in signal detection activities, including:
Data cleaning and review
Annotation of line listings
Creating supporting materials for signal review meetings
Preparing sections of signal reports
Required Qualifications & Experience
Education:
Bachelor’s/Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
Experience:
Minimum 2-4 years of experience in pharmacovigilance, regulatory writing, or safety reporting within the pharmaceutical or CRO industry.
Experience in safety writing and regulatory documentation for global submissions.
Familiarity with global pharmacovigilance regulations and regulatory agency guidelines (e.g., FDA, EMA, ICH).
Strong knowledge of safety databases, line listings, and case processing.
Skills & Competencies:
Excellent scientific writing skills with attention to detail.
Ability to analyze large datasets and summarize findings.
Strong organizational and multitasking abilities.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and safety database systems.
Effective communication and teamwork skills to collaborate with cross-functional teams.
About Fortrea
Fortrea is dedicated to advancing clinical trials and enhancing patient access through scientific innovation and collaboration. We foster an inclusive work environment where professionals can contribute to meaningful global healthcare advancements.
Equal Opportunity Employer Statement
Fortrea is an Equal Opportunity Employer (EOE/AA) and is committed to diversity and inclusion. We do not tolerate discrimination based on race, religion, gender, disability, veteran status, or any other legally protected characteristic.
For more details, visit www.fortrea.com.
If you require accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.
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