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Safety Report Writer- Remote

Company: IT People Corporation, Inc.
Location: Burlington
Posted on: January 27, 2023

Job Description:

Excellent opportunity to work with a global life sciences and healthcare company.
If your skills, education, or experience fit the role below, please apply for immediate consideration. -

Safety Report -Writer -

  • Experience with database technologies.
  • 5-7 years experience required.
  • Experience in authoring/review of aggregate reports and conduct safety analysis on complex datasets.
  • Keywords to look for can be PBRER, PSUR, Safety analysis, case analyzes, Signal detection, signal management, aggregate safety reports.

    • 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
    • Write and review various safety reports (or part of such reports) for global regulatory submissions for Labcorp's clients, including Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned
    • Author/review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports, responses to health authority requests
    • Prepare/review medical information responses for HCPs
    • Act as a writing coach and devise training programs
    • Author/review SOPs/WIs/process documents or sections as applicable
    • Impart/conduct Trainings for peers and team members
    • - - Coordinate activities related to various types of report writing across a team of writers if applicable
    • Liaise with client and act as a primary point of contact for all report writing activities
    • Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training
    • Internal and external (client) communication & co-ordination to get the required inputs
    • Get resolution on issues affecting project deliverables
    • Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document
    • Any additional activities as per the project requirement or manager's discretion on completion of relevant trainings

      This position is fully remote but will need the flexibility to work Eastern US time zones.

Keywords: IT People Corporation, Inc., Burlington , Safety Report Writer- Remote, Advertising , Burlington, North Carolina

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