Job Title: Safety Writing Assistant II
Location: Mumbai
Category: Clinical
Job ID: 2443859
Company Overview:
Fortrea is a global contract research organization (CRO) with decades of experience in clinical development. We provide comprehensive solutions for pharmaceutical, biotechnology, and medical device customers across over 20 therapeutic areas, with operations in around 100 countries. Fortrea is dedicated to transforming drug and device development to improve the lives of patients worldwide.
For more details, visit Fortrea.com.
Job Overview:
As a Safety Writing Assistant II, you will support the development of safety reports and assist with signal detection activities. You will be involved in tasks such as generating outputs, authoring safety reports for global regulatory submissions, and supporting medical writers in the preparation of safety-related documents.
Key Responsibilities:
Data Generation and Reporting:
Produce reports from databases or safety systems.
Distribute data requests and calculate sales data.
Perform regulatory website searches and collate report planning materials.
Report Writing:
Author sections of various safety reports (e.g., Annual Reports, Periodic Safety Update Reports, Risk Management Plans) for global regulatory submissions.
Develop assigned report sections, including pre-populated template text and safety analyses.
Review and annotate line listings, prepare case narratives, and present data according to approved strategies.
Support in Signal Detection:
Assist in data cleaning and review.
Help prepare supporting materials for signal review meetings.
Contribute to parts of signal reports.
Fortrea’s Culture & Values:
Fortrea emphasizes collaboration, growth, and making a global impact in clinical trials. Our Fortrea FOUR culture values include:
Forward Together
Own It
Uphold Integrity
Respect People
Equal Opportunity Employer:
Fortrea is an Equal Opportunity Employer (EOE/AA) and is committed to diversity and inclusion in the workforce. We make employment decisions based on qualifications and business needs, without discrimination based on race, religion, color, gender, disability, or other legally protected characteristics.
Accommodation Requests:
If you need accommodation during the application or interview process, please contact:
Email: taaccommodationsrequest@fortrea.com
(Note: This email is for accommodation requests only.)
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