[WFH / Pune / Mumbai] Fortrea Hiring Safety Writer

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[WFH / Pune / Mumbai] Fortrea Hiring Safety Writer

About Fortrea:
Fortrea, a global CRO, pioneers clinical development across 20+ therapeutic areas with 19,000+ staff in 90+ countries.

Position Name:
Safety Writer

Organization:
Fortrea

Qualification:

• B.Pharm
• M.Pharm
• Pharm.D
• M.Sc
• B.Sc in Lifesciences

Experience:
2 Years

Salary:
₹25,000 – ₹55,000 /month

Location:
WFH / Pune / Mumbai

Job Description:

Tasks & Responsibilities:

Task	Responsibilities
Data Collection & Planning	Perform data collection for report planning. Lead discussions for comment resolution.
Safety Report Writing	Write safety reports for global regulatory submissions (e.g., Annual Reports, PSURs). Collaborate with stakeholders. Perform quality reviews.
Common Technical Document Summaries	Write CTD Summaries and other regulatory documents.
Medical Information Responses	Prepare medical information responses for HCPs.
Signal Reports & Safety Issue Analysis	Author signal reports and safety issue analysis. Write subject narratives.
Communication & Coordination	Coordinate internally and with clients for required inputs.
Label Creation & Updates	Participate in creating and updating labels.
Literature Searches & Surveillance	Conduct literature searches and surveillance activities. Author summaries.
Process Improvement	Implement efficient processes. Ensure regulatory compliance.
Additional Activities	Perform project-specific activities as needed.

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