Safety Monitor II
Location: North Carolina
Clinical Research International
s a full-service contract research organization with
international resources dedicated to helping pharmaceutical and
biotechnology companies, efficiently and expeditiously navigate
the regulatory approval process in order to bring new drugs,
medical devices to the people who need them.
Safety Monitor II
Responsibilities include receipt and review of daily SAE faxes
for both initial and/or follow-up reports, renaming of files,
printing, logging, the sending of acknowledgments of receipt to
sites and the notifications of reports to project team and
Develops the guidelines, insures
the uniform and timely reporting of adverse events by providing
safety training to investigators, sites, project team members
and also project specific training to the internal safety team.
Timely processing of all adverse
events reports, acts as a liaison both internally and with
external collaborators to ensure steps and processes are
completed and prepares reports to meet regulatory reporting
requirements domestically and internationally.
Responsible for the compliance of
established SOP's and also the global regulatory requirements
for the reporting of adverse events to all regulatory
May provide safety advice on
study design strategies, analysis plans, coding and clinical
data review as well as field monitoring and drug development
Assists in the review of
protocols, CRFs pages, SPM, and customization of the SAE Report
and their Completion Instructions for sponsor specific projects.
Responsible for un-blinding, reconciliations (both interim and
end of study, proofing of monthly line listings to the sponsor,
assists in the preparation of Annual Reports, and updating of
the Investigator’s Brochure, Product Labelling and/or Package
Insert and other reports or listings as necessary.
Main tasks in the areas of Safety Evaluation include: Medical
coding and evaluation of data entry in the Safety database,
creation of case narratives in the Safety database, requests for
follow-up via designated work-flow, completion of ad hoc sponsor
projects, ensuring case files are logged and in chronological
order and discussion of coding issues with Medical Coder.
Bachelor's degree in health-related field or equivalent
Minimum of 3-5 years of clinical safety experience or Master's
degree and 2-4 years clinical experience.
Skills: Must possess and understand global safety regulatory
requirements and pharmacovigilance, medical coding with multiple
dictionaries, and proficient with multiple safety systems.
Must be able to work under time
constraints to meet regulatory reporting requirements and have
the ability to work on multiple simultaneous safety projects
while interacting with the project teams.
ability with attention to detail and excellent written and
verbal communication skills. Ability to maintain effectiveness
in a changing environment.
Knowledge of and insight into
general business principles and practices as well as current
business priorities and requirements.
Displays competency in required
job skills and knowledge. Demonstrates success in working in a
For applications or further information please email your CV