SUMMARY:

• Analyzes customer complaints, both medical and technical.
• Determine qualification of complaint potential adverse effect vs product technical complaint. Interact directly with customers, patients, pharmacies and Physicians.
• Document and maintain records of all complaint investigations in accordance with 21CFR 820.198.
• Creation, investigation and reporting of Medical Device Reports for submission to FDA if incident meets reportable criteria for both Malfunction and Serious Injury.
• Monitor and track Serious Adverse Events and non - serious Adverse Events drug reactions.
• Good understanding of upcoming new EU Medical devices regulation for both medical devices (MDD) and in vitro diagnostic medical devices (IVDMD).
• Knowledge of technical complaint vs. medical complaint.
• Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803.
• Experience with medical device reporting.
• Knowledge of hospital environment, point of care business and related regulatory environment.
• Understands and involvement with cGMP regulations.
• Knowledge of guidelines for medical device safety reporting requirements.
• Knowledge of FDA complaint regulations for drug products, biologics and medical devices.
• Accurately documents AE case data for Clinical studies, Drugs, Medical devices, biologics and including Oncological drugs.
• Knowledge of processing MedWatch cases.
• Electronics and mechanical troubleshooting skills. Knowledge of Quality System standards and regulations including 21 CFR 803 & 820 and ISO 13485 / 14971.
• MedDRA coding, ARIGg Drug safety database, REMS program. Strong understanding of GCP, GMP, GDP, GLP, ICH Guidelines and FDA regulations.
• Good understanding of FDA Medical devices classification, including the Premarket approval process or PMA and Premarket Notification or 510K.
• Performs all aspects of data entry including coding of events, determination of labeling, reportability, and completing cases within required timelines.
• Pharmacovigilance, Cases processing.
• Responsible for maintaining the quality processes associated with regulatory reporting and its procedures/controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards.
• Responsible for processing complaint files globally from Intake status to closure; including coding for USA, EU, China, Japan, Latin America, Australia and close files appropriately within 60 to 90 days to meet metrics.
• Responsible for the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.).
• Ensure accurate documentation of evaluation and investigation result of the complaint file; including literature files, and clinical files.
• Request SQM Review when complaint is confirmed.
• Medical devices classification III investigative experience in Drug delivery, Ophthalmics, Diagnostics, Surgical Systems and instruments (Surgical sutures and wound closures devices), In Vitro Diagnostic Medical Devices and including combination products. MDV & MDR
• Knowledge of International Organization for Standardization procedures. Interacted with Pharmacovigilance team regarding Adverse events. Responsible for the receipt and data entry of adverse event reports following Company Confidential Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies.

SOFTWARE & SYSTEM:

Operating Systems: XP, Windows Vista, Windows 7, Windows 8, 10 and MAC.

Office: Microsoft Word, Excel, PowerPoint and more.

QA and safety Database: Tantacom, Observer, Rocketware, COGNOS, Trackwise, Central Data Station (CDS), Data Exchange (DE), DELTA, Siebel, CRS, iTrack, Phit, AWARE, PTC Database, D2 System, Captiva, ARISg 6, 7.2.3, ARGUS 8.0, SMART Inbox, SMART Track, ECM Tool.

EXPERIENCE:

Confidential, Somerville, NJ

Product Complaint Specialist - Regulatory Reporting

Responsibilities:

• Responsible for the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.)
• Ensure accurate documentation of evaluation and investigation result of the complaint file; including literature files, and clinical files. Request SQM Review when complaint is confirmed.
• Responsible for processing complaint files globally from Intake status to closure; including coding for USA, EU, China, Japan, Latin America, Australia and close files appropriately within 60 to 90 days to meet metrics.
• Interacts with the RSS Team for seriousness assess opinion when determining whether serious injury occurred.
• Assess files for serious injuries and device malfunction, and code events accordingly into the ECM tool.
• Responsible to assess and review additional information and make MDR determination based on the additional information received. Interact with Manufacturing site by requesting DHR when lot is provided (Device History Record). Request Sample retrieval for analysis.
• Responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions. Submit clarification request and questions to relevant parties, including Sales Rep, Surgeons on device return status, product information and reported event.
• Process additional information and recommend and make changes into the file based on the additional information received.
• Evaluate all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
• Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service, Global Brand Protection and Technical Services.
• Good understanding of basic principles, theories, concepts and techniques related to customer complaints.
• Ensure compliance with the company's Quality System policies and procedures, as well as applicable external requirements and standards, including FDA (21 CFR), ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Health & Safety Practices, and other applicable standards as pertaining to medical devices.
• Be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Good knowledge of international standards and regulatory requirements, including, but not limited to ISO 13485 and 21 CFR, section 803 and 820. Responsible for maintaining the quality processes associated with regulatory reporting and its procedures/controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards.
• Responsible for both initial and follow up of regulatory submission for both Malfunction and serious Injury.
• Review reportable and potentially reportable complaints from incoming calls, faxes, and emails from all areas of the world.
• Ensure adequate information is received to warrant timely reporting, investigation, and closure of reportable complaints, including sound regulatory reporting decisions/justifications for worldwide reporting.
• Applies Confidential practices and procedures, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.
• Applies Confidential practices and procedures, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.
• Assists with the summary reporting for the US FDA. Responsible for updating files with new information into the ECM tool, asses that new information to determine what needs immediate attention, malfunction reporting, regulatory reporting and assisting with the final review of a triage of files before the case can be closed.

Confidential, Cherry Hill, NJ

Product Complaint Vigilance

Responsibilities:

• Evaluates adverse events and product quality complaints and conducts complaint investigation in accordance with Confidential Operating Procedures using the Product Quality Management System.
• Performs all aspects of data entry including coding of events, determination of labeling, reportability, and completing cases within required timelines.
• Performs accurate data entry based on source documents and the uniform and timely processing of adverse event reports including writing meaningful case narratives.
• Responsible for the overall processing of adverse event information in compliance with applicable FDA and global regulations and Confidential Operating Procedures (SOPs) and guidelines.
• Performs quality control of adverse experience information processed in the safety database and confirms expedited reporting to health authorities.
• Interact with Clinical team and other Drug Safety units in the review, processing, and reporting of safety information.
• Creates simple queries using the safety database.
• Acts as a liaison with internal and external business partners on Safety operation management issues.
• Triage and track incoming adverse event reports within one business day of receipt
• Handle the receipt, processing, monitoring, and reporting of product defect complaints, make MDR determination.
• Ensured the complaint process was completed in accordance with corporate procedures, follow complaint file all the way until completion.
• Creates summaries of the investigation, including the corrective action and preventive action. CAPA
• Collaborate with External Manufacturing Sites, Internal Manufacturing Sites, External Manufacturing QA, Business Quality, Medical Safety, R&D and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process.
• Processes serious product complaints according to internal Confidential Operating Procedures. Performs complaint case review, return sample evaluation, malfunction coding, as applicable, investigation by manufacturing site and escalation, as appropriate. Ensures all relevant data for complaints are obtained and well documented in accordance with closure timelines
• Strong knowledge of GMP regulations, ICH and ISO guidelines.
• Provide support and assistance in the evaluation of Product Complaints for Medical Device Report and Vigilance reports. Responsible for reporting of complaints, evaluation of returned products, in accordance with Corporate, Site, and department procedures, and regulatory requirements.
• Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action.
• Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries
• Responsible for communicating business related issues or opportunities to next management level.

Confidential, Horsham, PA

Pharmacovigilance Associate

Responsibilities:

• Performs all aspects of data entry including coding of events, determination of labeling, reportability, and completing cases within required timelines. Perform QC of ADE reports.
• Collects adverse event data on all marketed products and those in development. Implements and manages adverse event processes and databases. Liaise with Case receipt and/or medical Review staff as appropriate.
• Performs causality assessment based on USPI. Relatedness/Expectedness/Manual Coding
• Good knowledge of distribution rules (Regulatory Submission) for both serious and non-serious cases. (Labelled-Unlabeled/ Related/Not related) 3500A / 15-Day Alert / Paper eCTD / FDA E2B Serious Periodic/ FDA E2B Non-Serious Periodic.
• Ensures regulatory compliance for both expedited and periodic reports.
• Ability to manage multiple tasks / priorities simultaneously (coordination)
• Performs active pharmacovigilance with rapid identification and analysis of safety signals, to define emerging drug safety profiles of all products and drive patient risk management.
• Delivers high-quality product safety data and analysis to internal and external customers throughout the product life cycle
• Good knowledge of Pharmacovigilance regulatory environment ; PV Global case processing ARISg Database experience . Ensure proper coding of events and drugs for cases to ensure correct forwarding to the relevant Medical Review Team
• Execute QC on key fields of serious cases; determine follow-up needs for AE reports
• Review & update auto-narrative as needed. Enter applicable information into the global safety database (ARISg) for initial or follow up cases. (solicited and spontaneous reports)
• Contributes to process improvements.
• Good understanding of MedDRA coding conventions . Solves complex problems; takes a new perspective using existing solutions; works independently; acts as a resource for colleagues with less experience.

Confidential, Bridgewater, NJ

Drug Safety Specialist

Responsibilities:

• Responsible for the receipt and data entry of adverse event reports following Company Confidential Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies.
• Executed case assessment (reviewed events, determined labeledness, identified co-manifestations, review coding, determined causality).
• Detailed training in Data Entry, Case Processing, and Regulatory requirements of SAE Medical narrative writing. Participated in team meetings within the drug safety department.
• Independently analyzed case information for reportability based on US regulations, causality, events and drug/device code and made submission determination.
• Tracked all reportable case submissions to ensure cases were actually submitted to the FDA and troubleshoots submission failure.
• Provided feedback to USPV personnel to improve data entry quality and minimize submission errors.
• Identified and selected routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Assessed cases to distinguish those with particular complexities and/or specific issues, and escalated appropriately.
• Reviewed, ranked, verified, processed and documented: Verified the accuracy, completeness and validity of information for each adverse event report for which he/she was responsible.
• Requested for additional evidence by sending correspondence to Consumers, Healthcare professional when minimal information is provided to complete the AE report.
• Processed ADR reports from Consumers and Healthcare professionals received by Fax, and mails using the CAPTIVA software scanning system. Processed and entered cases into Siebel for triaging and prompt assessment.
• Determined seriousness criteria and prioritized based on the seriousness of the case.
• Assessed and processed adverse drug reaction report from the Patient support program and market research program.
• Wrote and edited the case narrative.
• Reviewed case criteria to determine the appropriate workflow for case processing.
• Ensured accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes.
• Performed appropriate and timely follow-up per department guidelines, including accurate and thorough communication documentation within the case. Accurate and timely data entry of both domestic and foreign adverse event and serious adverse event.
• Responsible for receipt and documentation of safety information for Marketed and Investigational Products.
• Gathered sufficient information to assess the medical significance of an adverse event report.

Confidential, Bridgewater, NJ

Product Safety Expert

Responsibilities:

• Performed integrity checks and file audits to ensure data consistency and identify missing data and/or attachments.
• Performed customer care activities including, but not limited to: Issuing refunds, credits, replacements and sending acknowledgement letters.
• Entered complaint data into designated safety database(s) using Good Documentation Practices (GDP).
• Coordinated sample returns and ensures they are sent to the appropriate investigation sites.
• Ensured accuracy of data received from other internal databases by researching and following up when necessary (customer returns and service requests). Performed complaint follow-ups, missing, additional information sample status and questionnaire status. Responsible for completion of specified activities to support complaint records management and other administrative/clerical activities as required facilitating complaint processing.
• Performed file reconciliation with: MIS, Customer Service, Non-TW Affiliates and Closure of complaints.
• Established and maintained the global complaint requirements and procedures with the assistance of Manufacturing and Verification partners.
• Reviewed potential complaint data received via safety system(s), phone, fax, mail, or other methods. Scanned attaches and documents additional information upon receipt (i.e. source documents including correspondence, medical records, receipts, and service requests). Responsible for comprehensive case management including confirmation of complaints, data entry, follow-up, assessment, regulatory report preparation, and final closure of the complaint file.
• Administrated access to the complaint management system and acts as Business Owner for the complaint management system.
• Interacted with the manufacturing sites for a prompt completion of the manufacturing investigation.
• Performed initial and subsequent evaluations of complaints including, but not limited to, seriousness assessments.
• Initiated manufacturing investigation when the sample was found to be out of specifications after receiving the result of the sample verification. Performed final reviews and closes all complaint records.
• Escalated the need for additional actions including, but not limited to, legal and product security issues, when appropriate.
• Medical Devices reporting (MDR form 3500A) CFR Part 803Review, assesses, and triage both medical and technical complaint.
• When necessary, ensured appropriate Medical Monitor reviews potential serious adverse event complaint records for seriousness of events. Provided global complaint data to management and complaint process partners. Facilitated the extension request and interim report (ERIR) process.
• Responsible for comprehensive case management including confirmation of complaints, data entry, follow-up, assessment, regulatory report preparation, and final closure of the complaint file.

Confidential, Princeton, NJ

Product Support/Complaint Specialist

Responsibilities:

• Provided direct technical support to internal and external customers on the business's portfolio of medical device products.
• Participated in the identification, implementation and monitoring of corrective and preventative actions initiatives as needed.
• Performed routine tasks assigned by the technical services management team.
• Analyzed complaints and diagnose probable causes.
• Evaluated, investigated, tracked and completed complaints through effective and established complaint handling process.
• Provided troubleshooting solutions, software update, and software installation.
• Provided guidance on how to run Quality control when new lot # of cartridges were received.
• Developed and generated reports associated with the Product Quality.
• Managed Product Quality Complaints to ensure Confidential process was followed, and data was consistent and of high quality to assist with correct decision making.
• Asked for the defective cartridges and the i-STAT Blood Analyzer to be retuned for investigation.
• Performed first line telephone troubleshooting that resulted in the most effective resolution of customer's technical enquiries.
• Provided problem analysis and technical clarification support services to both internal and external customers.
• Followed up with the customer via email fax and telephone.
• Visually inspected products for defects. Good understanding of Point of Care business.
• Performed a complete visual inspection on the defective product.
• Processed and analyzed product complaints according to Policies and Confidential Operating Procedures.
• Categorized complaint accordingly Level 1 or level 2 complaint as per Confidential SOP.
• Educated as appropriate and then follow-up as necessary. Assisted HCP on how to use a wide range of Cartridges for diagnostic testing. Good laboratory practices.
• Knowledge of performing a range of clinical test, including cardiac markers, lactate, coagulation, blood gases, chemistries, and electrolytes, and hematology. Diagnosed problems by asking accurate, concise questions in a professional and timely manner.
• Responsible for implementing and maintaining the effectiveness of the Quality System, document complaints in accordance with Quality standards, recognize and communicate trends in product issues and their impact on customers.
• Documented complaints in accordance with Quality standards. Ensured all relevant complaint data was obtained. Sample collection and cartridge handling procedure.
• Responded to simple and intermediate customer inquiries via multimedia channels, analyzed complaints, diagnosed probable causes, systematically eliminated alternatives, provided troubleshooting solutions, educated as appropriate and then followed-up as necessary.
• Assisted HCP on how to run calibration Verification and Quality Control on the i-STAT (Blood Analyzer). Documented the reportable event according to APOC SOPs. Good understanding of basic chemistry related to IVD testing.
• Evaluated product quality complaints for seriousness, correctness and consistency of categorization.
• Recognized and communicated trends in product issues and their impact on customers.
• Interacted with doctors and nurses answering questions and inquiries about Abbott medical devices.
• Answered calls arriving at the Support Center and to accurately identified, prioritized and logged the service requests within the established standards. Accurately prioritized, categorized and logged calls, reset network passwords, resolved print queue problems manage crisis escalation and transferred calls to other support group as appropriate, assisted in projects as needed.

Confidential, Bridgewater, NJ

Product Quality Complaint Analyst

Responsibilities:

• Handled and triaged incoming product complaints to the appropriate manufacturing and packaging sites.
• Performed routine tasks assigned by the PQC Management team.
• Interacted with Pharmacovigilance team in regard to Adverse Events which were also product complaints.
• Input data into PTC Global Database and Siebel System. Interacted with internal and external manufacturing sites to become knowledgeable with their product and processes. Knowledge of technical complaint vs medical complaint.
• Received and reviewed all customer complaint reports and identified any that may have had potential to cause an adverse event. Processed and analyzed product complaints according to Policies and Confidential Operating Procedures. Interacted with other company departments in regard the identification and evaluation of technical complaints.
• Interacted with complainant to resolve questions and ensure correctness of product complaint information.
• Reviewed and evaluated complaints to ensure appropriate action and closure.
• Ensured all relevant complaint data was obtained. Generated reports associated with the Product Quality Complaint.
• Processed non-serious product quality, adverse event and Lack of Effect complaints according to department procedures and external procedures as applicable. Evaluated product quality complaints for seriousness, correctness and consistency of categorization. Categorized product quality complaint accordingly.
• Coordinated the processing of product complaints to ensure compliance with all established procedures and regulations. Requested sample return from complainant if necessary, by sending a PPE.
• Categorized product quality complaint accordingly.
• Managed Product Quality Complaints to ensure Confidential process was followed, and data was consistent and of high quality to assist with correct decision making. Provided timely process and response to external customer for closure or product complaint.
• Differentiated between product inquiry and product complaint and forwarded to respective manufacturing site for prompt customer service. Detailed training in Data Entry, Case Processing, and Regulatory requirements of SAE Medical narrative writing.
• Interacted with product quality complaint handling, manufacturing and quality personnel at internal manufacturing sites and external partners. Interacted with safety and surveillance personnel at Global Medical Safety for investigation of adverse events with potential product quality issues. Provided support for internal audits and inspections by regulatory authorities.
• Interacted with the Sample Lab for product retrieval. Knowledge of processing MedWatch cases. Processed generic letters.

Confidential, Princeton, NJ

Bilingual Product Quality Complaint Coordinator

Responsibilities:

• Built customer loyalty by providing high quality customer service in response to inquiries from to patients, caregivers and health care professionals who contact the Patient Centric Customer Care Center about products and services.
• Documented product quality complaint, adverse event, and report them to Product Safety Department.
• Advice product replacement if necessary. Requested defective products returned to the Product Safety Department for further testing. Determined follow-up requirements and recommended follow-up if necessary.
• Determined qualification of complaint: potential adverse effect vs. product technical complaint.
• Interacted directly with customers, patients, pharmacies and physicians.
• Documented all customer contacts in the Customer Care database collected through phone calls, customer e-mail, and postal mail.
• Identified and reported all adverse events, product technical complaints and other safety information related to marketed products in compliance with FDA Regulatory requirements. Provided product support materials and educational materials to customers.
• Provided training on the proper use and storage of all Confidential products and devices. Provided technical assistance to customers related to product or promotional website issues.
• Provided professional, accurate, and timely responses to product information questions and other inquiries concerning products and services from customers via telephone, email, postal mail and emerging communication tools such as Chat, Text, and Social Media. Performed data entry of all customer contacts collected through phone calls, e-mail, and postal mail into the Customer Care database. Followed-up on action items and activities in support of the department and/or function in accordance with project plans and timelines. Collected all information from customers regarding adverse events, product technical complaints and advise of replacement/return procedures. Monitored and tracked Serious Adverse Events and non-serious Adverse Events drug reactions.
• Guided patients and Health Care Professionals on how to troubleshoot the Flexpens and the Victoza Pen.
• Provided educational and promotional materials such as coupons and booklets to patients.

Confidential, Langhorne, PA

Bilingual QA Analyst - Product Complaints - Pharmacovigilance

Responsibilities:

• Documented Product quality complaint, Adverse Event using the CRS and Acclaro System.
• Helped consumers, Pharmacists and Distributors with their orders, tracking and shipment information.
• Process White Mail in French, Spanish, and English.
• Verified implementation strategies align with Q&C objectives for relevant activities.
• Reviewed and provided input into controlled documents.
• Assessed regulatory impact on product and manufacturing processes.
• Assisted in the Quality Assurance Department by monitoring multiple agents’ phone calls in French, English and scoring accordingly.
• Monitored and provided feedback to agents based on their interactions with customers.
• Selected to coach and mentor new customer service representative.
• Processed product refunds by sending a check or replacement vouchers if necessary, to the consumers.
• Requested products returned to the Quality Department for testing by sending a quality mailer.
• Assisted in e-mails sent by consumer on inquiries, qualities and AEs or SAE.
• Assisted in the Mail Room inputting letters from consumers concerning inquiries, quality issues or medical issues.
• Determined follow-up requirements and recommend follow-up.