Pfizer Report Coordinator Bachelor’s Degree in life
sciences, healthcare, or pharmaceutical discipline
ROLE SUMMARY
Individual filling the position are responsible for the
project management of safety aggregate reports submitted to regulators that
include the FDA and EMA. The incumbent
will partner with various colleagues from safety, clinical, regulatory and
other functional lines to produce the aggregate reports and ensure that these
reports are completed in a timely manner meeting regulatory compliance.
ROLE RESPONSIBILITIES
Lead report coordination from prep to submission with key
stakeholders/contributors within Clinical, Regulatory, Safety, DevOps,
Submissions, etc.
Review data to ensure consistency between various
contributors.
Compile the information for reports using various
electronic tools and document management system.
Coordinate the review and approval of the report and
address review comments.
Ensure reports are completed prior to regulatory due date
to meet compliance.
Provide guidance to contributor regarding report
requirements.
Participate projects or subject matter tasks that support
the group and deliverables.
Participate in developing and performing User Acceptance
Testing (UAT) as required.
Complete training in accordance with Pfizer’s and WSR
Safety information Management curriculum.
QUALIFICATIONS
Bachelor’s Degree in life sciences, healthcare, or
pharmaceutical discipline required.
Excellent English verbal, written communication and
presentation skills required.
Must be detailed oriented.
Strong project management and issue resolution skills
required.
Demonstrated ability to perform in a cross-functional
environment.
Knowledge of regulatory/safety regulations and guidelines
desired.
Experience in the pharmaceutical industry, clinical
research, or healthcare related field.
Experience with Microsoft word & excel, Adobe acrobat,
ISI Toolbox, etc.
Experience with SharePoint technology (e.g., Microsoft
InfoPath, SharePoint Designer, etc.)
Business Objects experience is a plus.
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