Drug Safety Specialist - (Brookhaven, NY)

Receive incoming and outgoing telephone calls in the Drug Safety Department for Customer Complaints and Product Inquiries compliant with cGMP, FDA regulations and guidance, companys Standard Operating Procedures (SOPs) and practices. Triage customer complaints and inquiries in different types based on SOPs and log into the tracking logbook system and spreadsheet database system. Coordinate and arrange for the receipt of complaint samples and medical records from reporter / complainant / hospitals, medical facilities / Pharmacies, etc. Perform thorough documentation of case intake / follow up communication via complaints handling forms. Close out activities include response to customers