Senior Safety Writer and Process Lead

1 month ago


Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full time
Senior Safety Writer and Process Lead

Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

Key Responsibilities:

  • Generate line listings and summary tabulation, CFIs, CFCs.
  • Write and review various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.
  • Write Common Technical Document Summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents.
  • Author and review Risk Management Plans, ad hoc reports, and Safety Update reports.
  • Prepare medical information responses for healthcare professionals.
  • Coordinate activities related to report writing, including schedule oversight, team allocations, and communication with different teams.
  • Liaise with clients and act as a primary point of contact for all report writing activities.
  • Perform various support activities, such as tracking, maintenance of metrics, quality checks, and training.
  • Assist in estimating resource requirements and responding to RFPs as needed.
  • Internal and external communication and coordination to obtain required inputs.
  • Resolve issues affecting project deliverables.
  • Create and update labels, such as Core Data Sheets, USPI, and centralized SPCs.
  • Conduct literature searches for authoring reports and recommend label changes.

Requirements:

  • Ensure compliance with governing regulatory requirements.
  • Implement and promote consistent, efficient, and quality processes to meet timelines and deliverables.
  • Assume accountability for deliverables.

About Fortrea:

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We offer a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.



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