Scientist
Confidential
Thousand Oaks, CA
Full-time
Science
Posted on July 12, 2020
Amgen Inc.; Senior Associate Pharmacovigilance Operations, Thousand Oaks, CA. Examine, evaluate, and investigate eligibility for or conformity with laws and regulations governing contract compliance of licenses and permits, and perform other compliance and enforcement inspection and analysis activities not classified elsewhere. PROCESSING INDIVIDUAL CASE SAFETY REPORTS TO ENSURE HIGH QUALITY CASES PRODUCED IN A TIMELY MANNER TO MEET ALL WORLDWIDE REGULATORY AUTHORITY REQUIREMENTS; REVIEWING CLINICAL AND POST MARKET ADVERSE EVENT, PRODUCT COMPLAINT AND OTHER SAFETY FINDING CASES; FOLLOWING UP ON ADVERSE EVENT REPORTS AND INQUIRIES FROM PHYSICIANS, PATIENTS, AND PHARMACIES; SUPPORTING THE DEVELOPMENT AND DELIVERY OF CONVENTION-RELATED TRAINING MATERIAL; REVIEWING AND RESPONDING TO ADVERSE EVENT INTAKE, TRIAGE, AND SUBMISSION QUERIES IN A TIMELY FASHION; MANAGING UNBLINDING CASES, INCLUDING MONITORING UNBLINDING MAILBOX FOR UNBLINDING REQUESTS FROM MEDICAL SAFETY TEAM AND CASE PROCESSORS, CONFIRMING THE NEED FOR UNBLINDING FOR THE REQUESTED CASES, CHECKING IN SAFETY DATABASE WHETHER A PATIENT WAS GIVEN DRUG OR PLACEBO, PERFORMING DATA ENTRY INTO THE ARGUS DATABASE. Interested candidates send resume to: HR Connect c/o TM Review @ Amgen Inc., 2202 N. Westshore Blvd., Suite 250, Tampa, FL 33607 Attn. Job # (20516.244)