Manager -medical Writing
Hospira Healthcare India PVT LTD
5 - 7 yrs
Chennai
- PRIMARY FUNCTION:
- 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.
-W rite 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
-Prepare Standard Operating Procedures (SOPs) and templates
Company Profile:
Hospira Healthcare India PVT LTD
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