DIRECTOR
DRUG SAFETY
Location: Northeast
Responsible for establishing
a world wide drug safety program for premarket and marketed products. Initially, will
establish standard operating procedures for the management of drug safety information.
Responsible for the
establishment, validation, and maintenance of drug safety databases for all products.
Set up an adverse event
expedited reporting system and will be responsible for the production of periodic reports,
all according to current FDA and international regulatory requirements.
Will eventually oversee a
group responsible for the collection, medical review, sign off, processing, and analysis
of all safety and medical information relating
to products.
Review, update and provide
comment for clinical
study protocols, investigator brochures, and IND annual reports, and will review, comment,
and sign
off on all advertising, sales, and promotional materials.
Requirements include an
independent, detail oriented, systems person with a minimum of 10 years relevant clinical
or regulatory experience in the pharmaceutical or biotech industry.
An in depth knowledge of
global safety regulations in addition to planning and organizational abilities. The
successful applicant must be "hands on" initially,
with the ability to staff and grow a department.
|
