Akbar Jilani

Sr Executive Product Surveillance @Vantive

Gurugram, IN

Medical Device Complaint Management: Expertise in managing and monitoring medical device complaints, ensuring compliance with EU MDR guidelines, and reporting adverse events and malfunctions.2. Vigilance Reporting: Active involvement in EU MDR vigilance reporting, including timely submission of Manufacturer Incident Reports (MIR) and compliance with regulatory requirements. Complaint Handling: Proficient in various stages of complaint handling such as intake, Medical Device Reporting (MDR), investigations, and quality assurance.4. Complaint Intake Management: Experienced in handling mailbox complaints, assigning cases to the team, and ensuring complaint creation within established timelines (3 days).5. TrackWise Documentation: Skilled in creating complaints in TrackWise, conducting due diligence by following up with reporters for missing information, and ensuring accuracy in complaint records.6. Complaint Approvals: Verified complaint information, created associated records (e.g, Complaint Evaluation, EU MDR Decision Tree, and MIR), and ensured adherence to regulatory standards.7. Defective Sample Handling: Monitored defective sample status and coordinated shipping to investigation plants via UPS, ensuring proper tracking and documentation.8. Investigation Coordination: Assigned complaint evaluations to investigation plants, followed up for timely results, and ensured thorough resolution of issues.9. EU MDR Decision Tree (DT) Processing: Evaluated complaints using ARPC and DVAD codes to determine reportability per EU MDR 2017/45 guidelines.10. Vigilance Report Drafting: Drafted, reviewed, and submitted initial, combined, and final vigilance reports (MDR and MIR) to regulatory authorities within prescribed timelines (e.g, 15 days for initial reports).11. Customer Communication: Prepared and sent customer response letters (CRLs), providing investigation results and root cause analysis for complaints.12. Good customer service skills.

Sikkim University, Gangtok

Bachelor of Pharmacy - B.Pharm