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Drug Safety Associate/Senior Drug Safety Associate

Location: NJ
Industry: Pharmaceutical/Biotech
Job Code: 12024-08

Description:

The Drug Safety Associate will assist in the case processing of safety data from clinical trials and spontaneous post-marketing reports. They will also ensure timely reporting of SAEs to Regulatory Authorities, and cross-reporting to pharmaceutical partner(s). Adverse event information is handled in a manner consistent with departmental standard operating procedures as well as federal and international regulations.

Review serious adverse event reports to identify missing, inconsistent or erroneous data and check for duplicate cases

Process adverse drug and device experiences concerning marketed products or serious adverse event reports for investigational products.

 

Qualifications:

• B.S. in life science (ie: nursing, pharmacy, etc.)
• Requires a minimum of 1-3 years of relevant experience which includes 1 year in drug safety
• Broad knowledge of domestic and international drug safety regulations, industry practices and standards

 

CONTACT:

For more information on this or any of our other available positions or to be contacted by one of our staffing specialists, please send us your resume, cover letter and RegExec job code to resume.

PLEASE NOTE: All resumes that are received by RegExec will be thoroughly reviewed by one of our staffing specialists and treated confidentially.