DUTIES & ESSENTIAL JOB FUNCTIONS
• Handling product complaints:initiating/receiving, processing and closing as per applicable standard operating procedures ·
• Interacting with the customer/reporter on a daily basis to acquire information that may be required to effectively investigate a product complaint
o Analyzing the final investigations received from the manufacturing units to ensure accuracy
o Initiating/following up with Vice President Notifications to ensure technical issues are being address
• Following up with Corrective Action/Preventative Action plans to ensure technical issues are being address
• Accurately maintain product complaint logs (softcopy and hardcopy), and complete all filing and closing procedures
• Scanning completed product complaint files and sending to respective departments as needed
• To initiate the revision of standard operating procedures and/or working instructions relating to product complaints
• To initiate and handle deviations related to product complaints, and inquiries, adverse drug events as deemed necessary
• To assist in generating monthly, quarterly and annual metric reports
• To assist in handling medicalinquiries, completing appropriate forms and providing answers when applicable
• To assist in appropriately handling initial receipt of Adverse Drug Events {ADE) and processing it as per applicable
SOPs
• As deemed necessary, to assist in the handling and processing of field alert reports to the FDA
• Other projects, as deemed appropriate