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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