- Responsible for writing drug safety related documents.
MAJOR DUTIES AND RESPONSIBILITIES:
- Research, write and edit Drug Risk Management Plans (RMPs).
- Research, write and edit Drug Safety aggregate reports, such as PSURs, PBRERs, CASRs.
- Write Individual Case Safety Reports, Subject narratives (of significant adverse events)
- Ensure full quality assurance and quality control procedures are followed for all documents written. Conduct peer reviews and quality checks for other writers.
- Plan, coordinate and track the progress of the medical writing activities with other stake holders like medical monitors, clinical project managers, etc.
- Train and mentor junior writers. Company Profile:
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