Job title:Senior medical writer (parexel)

Location:india(remote)

Job Profile:
This role is responsible for managing the preparation and submission of various aggregate safety reports, including Periodic Safety Reports (PSRs), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and others. The position involves conducting signal detection and managing the end-to-end process of signal assessment, tracking, and analysis from multiple sources, such as regulatory databases, literature, and client data.

Key responsibilities include ensuring compliance with internal and regulatory timelines, maintaining knowledge of assigned drug safety profiles and clinical studies, preparing high-quality reports, and overseeing the performance metrics related to adverse event reporting. The role also involves liaising with clients, delegating tasks to junior writers, and participating in training sessions and audits. Additionally, the individual will address reviewer feedback, facilitate client communication, and ensure the successful delivery of accurate, high-quality safety reports in accordance with regulatory and internal guidelines.