Regulatory Affairs Associate / ADE Specialist (Adverse Drug Event)” –  Chicago area

Position Summary: Position is responsible for all stages of adverse event recording, processing, tracking, review, investigation, evaluation, reconciliation and reporting.  As a member of the Regulatory Affairs Dept, individual will also work on CMS preparations and ANDA submissions to the FDA

Experience Requirements:

• Minimum of at least 3-5 years experience in Drug Safety environment with experience in managing adverse event and SAE processing, risk management, and assessment;
• Knowledge of ICH/FDA guidelines for GCP and Clinical Safety Reporting;
• Experience with the use of global safety databases is a plus;
• Highly developed skills in verbal and written communication, planning, organization; 
• Extensive working knowledge of the investigational clinical study setting;
• Working knowledge of drug development process.

Educational Requirements: PharmD or other advanced degree

Compensation: Base Salary $75k, plus bonus. Company is flexible as to base salary for outstanding candidate.

Relocation assistance: Yes, but Chicago area candidate preferred.

Apply for this position now!