Safety Writer

Thepharmadaily LLP

Posted: 5 months ago
Openings: 10
Applicants: 0

Job Description

Fortrea is actively seeking motivated individuals to join our team as Medical Writers. As a Medical Writer, you will play a crucial role in various aspects of clinical research and regulatory submissions, contributing to the development of safety reports, regulatory documents, and other essential materials.

Key responsibilities include:

Perform data collection for report planning and strategy development.
Write safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and more.
Conduct quality review of safety reports prepared by junior or associate medical writers.
Author or contribute to ad hoc reports and benefit-risk evaluation reports.
Prepare medical information responses for healthcare professionals.
Contribute to signal reports and safety issue analysis reports.
Author subject narratives for adverse drug reactions and serious adverse events.
Participate in label creation and updates, including Core Data Sheets and Med Guides.
Conduct literature searches and review articles for various reports and surveillance activities.
Implement consistent and efficient processes to meet timelines and quality standards.
Ensure compliance with regulatory requirements and promote a culture of high customer service.
Perform additional activities as per project requirements and managers discretion.