Location Palo Alto, CA 94301 Stanford, CA 94305 Salary $75,000 - $100,000 Position Type Full-time, Employee Job ID SB-PA-DSA Recruiter Sharon Brown

Category Research Education Bachelor of Science Experience At Least 3 Years Skills Contract, Drug Safety Associate, Pharma, MedDRA, WHO DRUG Coding

Contract Drug Safety Associate

Salary: Max $55/Hour

Are you a talented Drug Safety Associate seeking a contract position through Spring of 2010? If so then read on!

We are a leading West Coast drug safety service provider (contract organization) to the pharmaceutical industry.

Job Description:

We seek a Contract Drug Safety Associate to work onsite at a client location in Palo Alto. EXPERIENCED PHARMA INDUSTR DRUG SAFETY PERSONNEL ONLY; THOSE WITHOUT DIRECT DRUG SAFETY PHARMA INDUSTRY EXPERIENCE PLEASE DO NOT RESPOND.

The DSA will work closely with the assigned project lead in the case processing of safety data from clinical trials and spontaneous post-marketing reports. The DSA 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.

The major duties and responsibilities will include :

• Process serious adverse event reports for investigational products of client.
• Triage cases by reporting criteria, expedited reporting vs. periodic reporting.
• Enter safety data into the client safety database with the ability to interpret the received report sufficiently to complete all necessary fields.
• Create a draft narrative of the event(s).
• Identify data requiring further follow-up and draft queries.
• Ensure regulatory compliance with timelines for individual expedited case reports submissions

Contractor Requirements:

~ BS, MS or Doctoral degree in a life science discipline, e.g., pharmacy, nursing, and a minimum of 2 years of relevant experience in pharmaceutical industry drug safety.
~ Knowledge of domestic and international drug safety regulations, industry practices and standards.
~ Must have a strong attention to detail, teamwork and initiative.
~ Knowledge of MedDRA and WHO DRUG coding dictionaries
~ Experience with drug safety database, Argus a plus

If you are a DSA looking for a great contract position in Palo Alto please send your resume today!

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Email your resume in Word to: Sharon.Brown@CyberCoders.com
**Please do NOT change the email subject line in any way. You must keep the JobID: CC WebJobApp : SB-PA-DSA — in the email subject line for your application to be considered.***

Sharon Brown - Senior Recruiter - CyberCoders

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