Website Tata Consultancy Services (TCS)
Role : Medical Writing (Aggregate Reports)
Exp : 7 years to 12 years
Location : Mumbai only
Preferred experience for the role: Minimum 7 years of Medical Writing experience, majorly in Aggregate reports (DSURs, PSURs, PBRERs, CASRs, PADs, Case Safety Reports, Subject Narratives (of significant adverse events) and Drug Risk Management Plans)
- Prepare and review drug safety related documents including but not limited to Drug Safety Aggregate Reports such as DSURs, PSURs, PBRERs, CASRs, PADs, Case Safety Reports, Subject Narratives (of significant adverse events) and Drug Risk Management Plans.
- Prepare safety and aggregate report related documents according to the Standard Operating Procedures, Document Standards and Guidance document.
- Provide training and/or consultancy to matrix teams on the internal and external standards and processes for producing clinical documents for regulatory submission.
- Gather and maintain information on project plans and timelines to plan resources.
- Review literature search and related documents.
- Initiate start up meetings with the Study Teams related to the creation and development. Share project timelines amongst the study team for the development of document.
- Ensure consistency and quality of the documents for regulatory submission and ensure the documents are following internal and external standards and are delivered within agreed timeline.
- To work in coordination with all the members in the study team- internal and external for the development of safety and aggregate report related documents.
Company: Tata Consultancy Services (TCS)
Vacancy Type: Full Time
Job Location: Mumbai, Maharashtra, IN
Application Deadline: N/A