Job Title: Pharmacovigilance Specialist
Job Location: Pittsburgh, PA, 15275
Job Duration: 05+ Months (Possibilities of Extension)
Shift: 8: 30 AM – 5:00 PM (Mon-Fri) (Hybrid role M and F WFH and Tues to Thurs WFO)
Job Description:
· Review written Adverse Events and/or Product Quality Complaint reports submitted to the drug manufacturer.
· Ensure timely and accurate transcription of data into the Client Quality Management System software and meet Client’s and manufacturer requirements and standards. Following QC checks ensure reports are submitted to manufacturer as required.
· Under the direct guidance and supervision of the Manager, Pharmacovigilance: Monitor and audit all potential sources of safety information including (but not limited to) recorded calls, claims, faxes, text messages, chat logs and other records for the presence of Adverse Events and/or Product Quality Complaints. Ensure all safety data found is captured, recorded, and reported per company SOPs.
· Assist Pharmacovigilance teammates with tasks such as periodic reconciliation, records inspection, or internal audit activities.
· Under the direct supervision of the Manager, assist with internal audit support, and preparation for 3rd party audits.
· Other duties as assigned "
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