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Drug Safety Associate
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Country: USA
Location: Massachusetts-Boston South Rockland, MA 02370
Total applied: 40
Job Category:Biotech/R&D/Science
Relevant Work Experience:2+ to 5 Years
Education Level:Bachelor's Degree
Location:Rockland, MA 02370
Status:Full Time, Temporary/Contract/Project
Occupations:Biological/Chemical Research;Clinical Research;Pharmaceutical Research
Career Level:Experienced (Non-Manager)
Relevant Work Experience:2+ to 5 Years
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Drug Safety Associate
DRUG SAFETY ASSOCIATE
COMPANY INFO:
MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.
Our client is a leader in the biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve patient's lives and is seeking to add a Drug Safety Associate to their team in MA.
RESPONSIBILITIES:
" Review and medical evaluation of clinical trial cases including source data verification and narrative preparation
" Participate in the development and writing of safety sections of Periodic reports (IND, ASR, SUSAR, PSUR)
" Support SAE reconciliation for Oncology clinical trials
" Participate in the development and writing of safety sections of Investigator Brochure and IMPD
" Particpate in the development and writing of Drug Safety Manuals
" Maintain and coordinate documentation regarding SMC meetings and decisions
" Participate in the review of study protocols and study reports
EDUCATION:
" BS Degree in Nursing, Pharmacology or Life Science with previous clinical drug safety experience including case assessment for expedited reporting, narrative writing and supportive roles in submissions and/or periodic reports.
MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.
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Biotechnology & Pharmaceuticals