Saif Alchalabi

Review medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or Vigilance reportability. Interact with cross functional teams (e.g. Customer Service, Complaint Evaluations Group, and Complaint Investigations Group) to gather appropriate information to determine whether a complaint requires an MDR and/or Vigilance report and/or submit an MDR/Vigilance follow up report. Document-filing decision rationale in the Complaint Handling System. Filing of all medical events and reportable malfunctions within the required timeframe. Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case. Perform verification of MDRs/Vigilance reports, including support of data compiled for metrics, risk evaluations and various other activities. Assure compliance to the division's Medical Event and Quality System procedures ,and Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis Reviewed regulatory submissions to ensure compliance with industry standards.

Processed and submitted prior authorization requests for prescription medications, ensuring compliance with payer-specific criteria and reducing turnaround time for approvals. Verified insurance coverage and coordinated with providers to resolve billing discrepancies, improving claim acceptance rates and minimizing denials. Utilized pharmacy management systems (e.g., PioneerRx, QS/1, or McKesson) to manage patient profiles, medication histories, and third-party billing workflows. Communicated with insurance companies, PBMs, and prescribers to clarify coverage issues and expedite medication access for patients. Maintained accurate documentation for audit readiness, including billing logs, authorization records, and reimbursement reports. Supported compliance with HIPAA, Illinois Pharmacy Practice Act, and CMS guidelines during all patient interactions and data handling. Assisted in inventory management, prescription filling, and patient counseling under pharmacist supervision.

Track reportable cases and report to regulatory authorities, ethics committees, institutional review board, investigators. . Perform quality control of safety data. . Attend project team meetings and provide feedback to the line manager on any challenges. . Read and acknowledge all necessary SOP and customer SOP as required. . Identify and record quality issues and escalate to regulatory reporting.

Key Responsibilities: Prepare and submit regulatory documents to agencies like the FDA, EMA, or Health Canada. Monitor changes in laws and regulations that affect product development and market access. Advise internal teams (R&D, quality assurance, marketing) on regulatory requirements. Ensure labeling, packaging, and advertising meet legal standards. Coordinate product approvals, renewals, and post-market surveillance. Support audits and inspection.