SENIOR Safety Associate - 4C Pharma Solutions
(2024-08)
Handling end-to-end complaint investigation and vigilance reporting for IGTS & SRC medical devices, including review, classification, root cause analysis, regulatory reportability assessment, and timely submission to health authorities.
- Conduct detailed root cause analysis (RCA) for complaints to identify product, process, and usage-related failure trends. Handling of investigation/closure of the complaints in SAP, Trackwise.
- Coordinate with FSEs', RSEs', NSS Teams to gather additional information about the complaints.
- Coordinate with the Technical/R&D team for further investigation as per customers' expectations.
- Coding of reported problem codes, problem source and problem reason codes for alleged complaints as per IMDRF.
- Writing of investigation summary for both reportable and non-reportable complaints based on technical product analysis data.
- Performing Global Decision Tree to determine reportability criteria for submissions to health authorities.
- Experience in Good faith efforts, where the process of getting additional information from the customer led to processing the complaints with full data. Experience as QA in investigation and closure team to close all the reportable and non-reportable complaints. Knowledge on mapping the correct codes based on the complaint scenario. Processing the End-to-end complaint handling and documentation process in the SAP tool.
- Draft and send Customer Response Letters' (CRLs) and Submitter Response Letters' (SRLs) based on investigation outcomes.
- Responsible for submission of MedWatch reports and serious adverse event cases to global regulatory authorities, including US FDA (MDR), Health Canada, MIR, and IRIS in compliance with regulatory timelines.
- Prepare, review, and submit regulatory vigilance reports ensuring accuracy, completeness, and adherence to applicable regulations.
- Coordinate and follow up with consumers and healthcare professionals to obtain additional information required for complaint investigation and regulatory reporting.
- Maintain thorough knowledge of SOPs, 510(k) device information, Master Regulatory Files, and current FDA and global regulatory requirements to ensure ongoing compliance.
- Utilized Trackwise and SAP to extract data and provided comprehensive QA findings based on data reviews, reporting issues and implemented process improvements where that will increase efficiency and reduce error rates.
- Having knowledge of Medical Devices standards and regulation including IS0 13485, ISO 14971, FDA 21 CFR part 820.
- Responsible for processing complaint files globally from Intake status to closure and close files appropriately within the timelines to meet metrics.
- Familiarity in risk assessment, hazard & severity determination based on the Product Risk Management.
- Taking on a lead position with responsibilities for assigning daily work, managing customer interactions, and participating in weekly calls.
Technical Consultant - L&T Technology services
(2023-06 - 2024-04)
- Handled Level 3 medical device complaints
- Coordinated with Field Service Engineers
- Drafted investigation summaries
- Managed escalations and ensured timely closure
QA & QC Trainee - S3V VASCULAR TECHNOLOGIES
(2022-12 - 2023-06)
- QA documentation & cQA support
- IPQA for hydrophilic coating (Pre & Post QC)
- Raw material QA, HPLC validation, release kinetics
- Audits, validation & regulatory exposure
