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TSRI Life Sciences is currently seeking
a qualified, experienced Drug Safety Specialist.
JOB SCOPE
Primary responsibilities associated
with this position is to receive and oversee compilation
of adverse event data and analyze data from clinical
trials and spontaneous reports for multiple therapeutic
areas. The Specialist will also play the initial
role of signaling to management those AEs which may
result in possible changes to drug labeling. The
specialist if further responsible for the preparation of
the periodic NDA and annual IND reports for the US.
The job requires the synthesis of the event into a
cogent medical narrative summary and the evaluation and
entry of the data into our proprietary computerized
database within timeline receipt of the initial
information.
RESPONSIBILITIES
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R.N. (RPh.
or PharmD or PhD in pharmaceutical space).
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1+
years related safety or clinical experience in
industry preferred.
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Demonstrated strength in written and communication
skills.
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Computer literate (training provided in client's
proprietary computer system for safety reporting).
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Ability to interact with colleagues, outside health
care professionals and consumers.
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Knowledge of US and non-US regulatory requirements
for safety reporting and labeling, preferred.
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