[jsfg_cinti] Regulatory Affairs Drug Safety Specialist - Cambridge, MA

Hi, 
I am assisting to recruit a Drug Safety Specialist for a NASDAQ listed
Cambridge, MA company pioneering the development and manufacturing of a new
class of intravenously administered pharmaceuticals.
The Drug Safety Specialist will have primary responsibility for development
and implementation of standard procedures for all aspects of adverse event
management activities, including the receipt, classification, processing,
reporting, performing follow-up on, and closing of adverse events received
from clinical trial and post-marketing sources worldwide. Secondary
responsibilities include providing safety support for clinical programs,
preparing periodic safety update reports and developing a worldwide safety
plan. 
Responsibilities: 
*       Developing and implementing standard procedures for adverse event
management activities worldwide
*       Receiving, classifying, processing, reporting, performing follow-up
on, and closing adverse events received from clinical trial and
postmarketing sources worldwide in accordance with regulatory reporting
timeframes and procedures
*       Assisting in the implementation and maintenance of the global safety
database.
*       Assisting in the development of data handling and coding conventions
for adverse events received from clinical trial and postmarketing sources
*       Providing safety support clinical programs
*       Specific responsibilities include participating in clinical trial
working group meetings, reviewing study protocols, informed consent forms
and the Clinical Investigator's Brochure and training clinical and
investigational study site personnel on safety-related definitions and
procedures for adverse event reporting
*       Preparing the safety section of the Annual IND Update Report and
Periodic Safety Update Report.
*       Ensuring product labeling pertaining to safety is accurately
conveyed and current
*       Developing a safety plan.
*       Managing medical information requests received from regulatory
authorities and other external sources
Qualifications: 
*       A BS in a scientific discipline (Masters Degree preferred) and a
minimum of five years adverse event management experience is required
*       Candidate must have a working knowledge of pharmacovigilance
concepts and domestic and international adverse event reporting requirements
*       Candidate must be able to analyze and compile accurate aggregate
clinical data within required timeframes
*       Candidate must possess exemplary communication and interpersonal
skills
*       Candidate must be detail-oriented and capable of working both
independently and in a team-oriented working environment
*       Previous supervisory experience, experience with adverse event
management systems and the Medical Dictionary for Regulatory Activities
(MedDRA) is desirable
If you are interested, please forward your CV along with salary requirement,
a cover letter addressing your specific qualifications relating the position
and your relocation considerations, if any,  to
resumes@xxxxxxxxxxxxxxxxxxxxxxxx  Please reference the position in the
subject line of your email to insure your information is routed to the
appropriate recruiter.
Senior Recruiter
Work Wonders Staffing
http://www.workwondersstaffing.net




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