Falguni Patel
Piscataway,NJ
Summary
A health care professional with more than 14+ years of experience in medical field. 3+ years of experience as in Drug safety associate, 5+ years of experience as in Lab technician, 5 years of experience as in Patient service supervisor and 1 year of experience in compliance coordinator.
Overview
13
13
years of professional experience
Work History
US Drug Safety Assistant
Pfizer Inc
07.2021 - Current
- Monitor and manage DSU mailboxes
- Maintain local documentation as required by legislation, including archiving, tracking, retrieval
- Support the submission and distribution of reports and relevant tracking
- Support of distribution of follow up letters
- Archiving as per company’s SOPs
- Consistently apply case receipt policies and practices as per Company SOP
- Consistently apply Archiving policies as per company policy
- Execute local activities relevant to the management of safety data
- Determine and perform appropriate case follow-up, including generation of follow-up requests
- Supported inspection preparedness activities
- Manage daily white mail by stamping, scanning and sending them to AER system
- Assist in handling the initial receipt of medical inquiries, ADEs for proper response
- Processing/QC first letters using GFA tool to process in Argus
- Perform 5% QC on vendor assignments
- Create vendor metrix report on weekly, monthly and yearly basis.
Patient service supervisor
Labcorp
10.2016 - 06.2021
- Manage patient flow, wait times, and inventory levels and information logs
- Monitor monthly productivity and report any deviations as necessary
- Coordinate phlebotomists' schedules through resourceful and creative thinking
- Perform operational duties such as payroll, monthly schedules and performance appraisals
- Partner with Human Resources regarding employee relations issues and disciplinary actions
- Hire and train phlebotomists to fill any open positions
- Communicate effectively to internal and external customers including patients, client office staff, sales team, logistics and senior management
- Provide exceptional customer service to all patients and clients
- Supervise a team of (+25) phlebotomists working in Patient Service Centers and/or physician's offices
- Assist in the set-up of new Patient Service Centers or Client Offices
- Provide resolution of any patient or client issues
- Perform, collect and prepare specimens when needed
- Travel to additional sites as necessary
- Prepare aliquot and store patient specimens per company SOP
- Track and ship specimens to reference lab as per special testing requirement
- Intake patient data, such as insurance, medical history, personal information in confidential manner
- Ensure the system of sending result in timely manner
- Maintain/order medical supplies on as needed basis
- Understand and comply with OSHA and compliance regulation.
Legal and Compliance Consultant/trainer
Prostakan, Inc
09.2015 - 09.2016
- Collaborated with the sales and legal department in reviewing HCP inclusion forms and their respective supporting documents
- Reviewed and analyzed HCPs inclusion forms in collaboration with sales operation team to meet quarterly payout for the sales force
- Utilized MEDPRO system to validate HCP licensed practitioners
- Provided data analysis and created reports on quarterly basis of provides that were validated through the verification process
- Transcribed data on to Excel sheet and provided analysis on needed basis
- Assisted Legal department in processing Sunshine Act process which included scanning, uploading the event attendance forms and receipts used by sales force
- Provided training to new hires for system and SUNSHINE ACT
- Assisted Compliance internal audits in collaboration with Chief Compliance Officer
- Process and archiving of pharmacovigilance reports and relevant tracking
- Supported in inspection activities and Audit according to FDA regulation.
- Trained and mentored 7 new personnel hired to fulfill various roles.
Lab Supervisor
Philip J Bean/ Medstar Medical Center
08.2011 - 09.2015
- Maintained Quality control testing on instruments such as Dimension EXL, Pentra 80XL, CA500 to verify equipment functions by SOPs on Daily Basis including Calibration, troubleshooting and performing routine maintenance
- Performed manual testing such as B-HCG, Mono Spot, H.Pylori, urine dipstick as well urine microscopy
- Analyzed and ensure quality results and identified any abnormal patient results and communicated with physicians
- Prepared and collected drug testing specimens following standard procedure
- Followed regulatory requirements of OSHA, CLIA as per company policy manual
- Gave proper guidance to team and any new hires with ease
- Maintained medical supplies for lab and instruments.
Education
Diploma in medical Laboratory Technology (MLT) -
Baroda Institute of Science - Vadodara
Gujarat, India01.2009
Bachelor of Science in Microbiology -
M.B.Patel Science College- S.P University
Gujarat, India01.2008
Skills
- Proficient in Microsoft Office Suite including Word, Excel, Outlook, drug dictionary, Argus and eRIM
- Proficient in Nextgen application for electronic health record (EHR), Orchard application system
- Sound understanding of applicable corporate and global regulations, guidelines, Standard Operating Procedures, Work instructions (WIs), local working guides and compliance monitoring
- Quick learner, attention to details, proven effective team member who can work effectively under pressure with excellent analytical and problem-solving skills
- Great communication, organization, prioritization, and time management skills
- Maintains highest ethical standards, including commitment to company values and behaviors
- Strong organizational, interpersonal and communication skills to plan and accomplish goals
- Team-oriented approach to project management and problem resolution
Timeline
US Drug Safety Assistant
Pfizer Inc
07.2021 - Current
Patient service supervisor
Labcorp
10.2016 - 06.2021
Legal and Compliance Consultant/trainer
Prostakan, Inc
09.2015 - 09.2016
Lab Supervisor
Philip J Bean/ Medstar Medical Center
08.2011 - 09.2015
Bachelor of Science in Microbiology -
M.B.Patel Science College- S.P University
Diploma in medical Laboratory Technology (MLT) -
Baroda Institute of Science - Vadodara
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