Description :
Overview :
The Pharmacovigilance Specialist will have primary responsibility for the receipt, evaluation, documentation, and reporting of adverse event information from clinical trials and from diverse post-marketing sources in accordance with company standard operating procedures, FDA regulations, and ICH guidelines.
Responsibilities :
Assess adverse event reports from clinical trials and post-marketing sources for seriousness, expectedness, and regulatory reportability
Process adverse event reports for expedited and periodic submission to regulatory agencies within appropriate timeframes
Code adverse events, product indications, medical history, and laboratory data using MedDRA; code concomitant medical products using the WHO Drug Dictionary
Write narrative descriptions of adverse events
Perform active follow-up of reported adverse events via telephone and in writing to obtain quality safety data from healthcare professionals and consumers
Review the published scientific literature for product-related adverse events and other safety-related issues
Prepare quarterly and annual post-marketing periodic reports for submission to FDA
Participate in the reconciliation of clinical trial adverse event data
Conduct searches of the safety database to retrieve adverse event data
Assist in the review of aggregate safety data
Participate in the preparation of responses to safety queries received from internal customers, regulatory agencies, and healthcare professionals
Provide professional support to all departments for safety-related issues
Qualifications :
Minimum B.S. degree in pharmacy or nursing (advanced degree preferred)
Current professional license in good standing is preferred, but not required
Minimum 2 years' practical experience in a clinical setting
1-2 years' pharmaceutical/biotechnology industry experience in a product safety department
Knowledge of U.S. Code of Federal Regulations and ICH guidelines pertaining to pre- and post-marketing adverse event reporting of drugs, biologics, and/or devices
Working knowledge of commercial safety databases
MedDRA and WHO Drug Dictionary coding experience strongly preferred
Excellent clinical interpretation skills
Strong knowledge of medical terminology
Experience with Microsoft Office packages (including Outlook, Word, and Excel)
AA/EEO Employer