Clinical Quality Assurance Associate - (FY09-42)

Job Description:
To provide support to drug safety and pharmacovigilance group to ensure that the regulations governing the processes are met and to provide input into new and ongoing systems development. To audit internal and external processes and vendors as indicated to ensure compliance with SOPs, Regulations, and Best Practices.

Minimum Education & Experience Requirements:
Healthcare professional (e.g., degree in nursing or pharmacy or allied health). Minimum of 5 years experience in US Drug Safety/Phamacovigilance and/or phase I-IV pharmaceutical industry clinical trials. Experience in EX-US pharmacovigilance/drug safety and/or clinical trials a plus. Experience in the auditing of clinical trials.

Knowledge/Skills Needed:
Knowledgeable in US, EU, and ICH Drug Safety/Pharmacovigilance regulations and guidelines. Good interpersonal skills. Excellent oral and written communication skills.

Personal Attributes Needed:
Ability to work with cross functional groups; handle difficult people/situations under pressure.