Job Title: Safety Writing Assistant II
Location: Mumbai
Category: Clinical
Job ID: 25364
Company Overview:
Fortrea is a global contract research organization (CRO) that works with pharmaceutical, biotechnology, and medical device companies. They offer a wide range of clinical development, patient access, and technology solutions, operating across more than 100 countries. Fortrea is dedicated to advancing clinical trials and drug development for better global health outcomes.
Job Overview:
As a Safety Writing Assistant II, you will support the preparation and review of safety reports, including risk management and signal detection activities. Your tasks will involve assisting with data collection, content development, and contributing to the completion of various safety-related reports. This role requires attention to detail, collaboration with the writing team, and ensuring the timely delivery of high-quality reports to clients and internal stakeholders.
Key Responsibilities:
Safety Report Writing:
Author parts of safety reports for global regulatory submissions, such as Annual Reports, PSURs, Risk Management Plans, and more.
Develop sections of reports using templates, pre-populated content, and data summaries.
Review and annotate line listings, case narratives, and other report components.
Participate in comment resolution and finalizing report content.
Signal Detection and Data Support:
Support signal detection activities, including data review, cleaning, and annotation.
Assist in preparing materials for signal review meetings and signal evaluation reports.
Literature Review and Abstracts:
Conduct literature searches, select relevant articles, and prepare abstracts or summaries for inclusion in safety reports.
Ad-hoc Reports:
Support preparation of safety issue analysis reports and documents related to label updates.
Collaboration and Support:
Work closely with medical writers to assist with strategy execution and report development.
Ensure reports meet quality standards and regulatory requirements.
Process and Compliance:
Implement efficient and consistent processes for report delivery.
Ensure compliance with regulatory standards and company SOPs.
Qualifications:
Education:
A degree in life sciences or a related field.
Relevant experience may be considered in lieu of formal educational requirements.
Experience:
At least 6 months to 1 year of experience in the pharmaceutical industry.
Scientific or clinical research experience is desirable.
Skills:
Excellent command of written and spoken English.
Strong communication skills and the ability to work in a team.
Good organizational and time management abilities.
Familiarity with MS Office and regulatory requirements.
Preferred Qualifications:
Advanced Degree: Master's or PhD in a relevant field is preferred.
Physical Demands/Work Environment:
Office or remote work environment.
Occasional travel (5%) may be required for project needs.
Fortrea’s Culture:
Fortrea fosters a culture of Forward Together, Own It, Uphold Integrity, and Respect People. They are dedicated to innovation and overcoming barriers in clinical trials, ensuring a collaborative workspace where personal growth is supported.
Equal Opportunity Employer:
Fortrea values diversity and inclusion, ensuring equal opportunities for all candidates regardless of race, gender, disability, or any other legally protected characteristic.
For more details on how we collect and store personal data, please refer to Fortrea’s Privacy Statement.
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