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Safety writer
3 months ago
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
Ensure compliance of operations with governing regulatory requirements
Create, maintain and assume accountability for a culture of high customer service
Efficiency in conducting literature searches for authoring various types of reports
Author/review various safety reports (or part of such reports) for global regulatory submissions for Fortrea’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned.
Perform/review Signal detection activities
Author/ review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
Perform allied activities like: Generation of line listings and summary tabulation, CFIs CFCs
Search literature databases for relevant information, recommend label changes, author proposed label text and prepare supporting/justification document
Author/review SOPs/WIs/process documents or sections as applicable
Impart/conduct Trainings for peers and team members
Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
