SUMMARY

• Approximately 7 - years experiences as BA/QA/ Pharmacovigilance associate with extensive experience in healthcare, pharmaceutical and health insurance industries
• Sound knowledge of Health Insurance and Portability and Accountability Act (HIPAA)
• Well versed with FDA guidelines, rules and regulations
• Strong knowledge and experience in Healthcare industry. Functional knowledge of Medicaid Management Information System (MMIS).
• Strong knowledge of medical information and drug information in Pharmacovigilance database utilizing MedRA and WHO-DD dictionaries.
• Worked with HL7, EDI ANSI 4010 and 5010 Standards. Involved in a migration process and respective GAP Analysis.
• Identified the mappings required to transform the HL7 messaging such that it would satisfy each systems, the interfaces were configured.
• Involved in mapping between two or more interpretations of the HL7 standard to resolve data model or workflow issues between incompatible applications. Reading a database and creating an HL7 message
• Expertise in EDI HIPAA Project to convert EDI X12 Healthcare 4010 transactions into 5010 Complaint transactions.
• Worked on 837 (I, P, D), 834, 835, 820, 270, 271, 276, 277, 278 transactions and BRCs of the transactions.
• Exposed to using ICD 9/ICD 10/ANSI/HL7 coding standards in Medicare and Medicaid domains of the healthcare systems and industry for both inpatients, outpatients, Reimbursement methodology.
• Implemented various HIPAA codes (270 and 276) used for Billing and Eligibility purposes of patient records.
• Have Process documentation creation experience and ability to facilitate requirement sessions and proof of concept sessions
• Have strong experience in requirements gathering by conducting interviews with end users
• Comprehensive knowledge of Software Development Life Cycle (SDLC), having thorough understanding of various phases like Requirements, Analysis/Design, Development and Testing
• Exposure in Forward Mapping and Backward Mapping analysis of ICD 9 - ICD 10 Conversion for CM (Diagnosis Codes) and PCS (Procedure Codes).
• Experience in conducting UAT (User Acceptance Testing) and documentation of test cases, ability to communicate both on a business and technical level and experience in coordination with business and technical resource
• Good control on MS Office suite, MS Visio and MS Project.
• Adept at creating and transforming business requirements into functional requirements and designing business models using UML diagrams - Context, Use Case, Sequence, Activity diagrams in MS Visio and Rational Rose
• Organized many Joint Application Developments (JAD) sessions, scrum meetings and Joint Requirement Planning sessions (JRP), walkthrough, Interviews
• Workshops and Rapid Application Development (RAD) sessions with end-user/clients/stake holders and the IT group
• Excellent presentation skills with MS Power Point, which was extensively used in different JAD sessions and to track progress. Communication ability with prospective vendors
• Assisted the project manager with activities like development of business processes, effort estimation, resource management, issue/risk analysis, milestone tracking and associated documentation
• Comprehensive knowledge of RUP, Agile, Scrum, FDD, Waterfall Methodologies
• Extensive experience in gathering, managing and documenting business requirements and functional requirements, communicating effectively with upper management, senior BAs, developers and QA engineers
• Excellent track record for meeting deadlines and submitting deliverables on time
• Excellent documentation, communication and interpersonal skills

TECHNICAL SKILLS

Operating System: Window 2000 / XP / Vista / Unix / Dos

Languages: SQL, HMTL, SAS

Application Management Tools: Rational Rose, Rational Requisite Pro, Clear quest, Clear case

Databases: MS Access, DB2, Oracle 8i, MS SQL Server, MedRA, WHO-DD

Microsoft Applications: Word, Excel, PowerPoint, SharePoint

Workflow Tools: MS Visio, MS Project

PROFESSIONAL EXPERIENCE

Confidential, Quincy, MA

BA/QA

Responsibilities:

• The review process includes identification and improvements in current documentation practice that will assist in establishing the Testing Center
• Analysis on the BRD structure, addressing area as well as focusing on the completeness and clarity of the requirements.
• BRD analysis was classified projects into 3 categories - not applicable (N/A) for enterprise testing, ready for scenario development and needing additional information to complete the development of testing scenarios.
• Used MS Visio for Process modeling, Process mapping and Business Process flow diagrams.
• Involve in the review and analysis of the BRDs employed a number of artifacts which will continue to be working documents to record the progress and traceability of test preparation, testability analysis report
• A detailed business requirements analysis checklist for each project, communication log with comments, questions and responses and functional area analysis summary with status of all submitted projects.
• Involve in functional area analysis report is used to report the overall status of projects. It reports the key summary data, as well as the current status of open questions and missing information for each project.
• It enables QA to review status of projects based on a number of criteria such as Impact area, open questions, information required and functional area.
• I had worked on total of 14 different functional area including, Benefits, Enrollment, Medicare, Customer service, Pharmacy, Med Management, Payment and pricing policy, Quality, Analytics, Sales, IA Fraud and preventions.
• Key findings were concern with the business requirements and supporting artifact analysis categorized into their respective functional areas; key decisions required QA status, testing complexity, and area of impact.
• Key impacts documented in the analysis focused on the financial integrity, benefit neutrality and operational stability objectives of the remediation effort.
• Working tools used were MS Office, Visio.

Confidential, Raleigh, NC

Healthcare Business Analyst

Responsibilities:

• Perform a baseline assessment of Hospital-Provider systems and related interfaces, the existing service level agreements and/or policies and operational business procedures for readiness to comply with HIPAA as well as ICD-10 requirements
• Have strong experience in requirements gathering by conducting interviews with end users
• Actively worked on Data analysis and Report analysis with respect to ICD-10 impact
• Analyzed System flows of various department of the hospital
• Identified risks, problems, requirements and concerns of the Hospital in order to comply with ICD-10 changes.
• Assisted JAD sessions to identify the business flows and determine whether any current or proposed systems are impacted by the EDI X12 Transaction, Code set and Identifier aspects of HIPAA.
• Identified the mappings required to transform the HL7 messaging such that it would satisfy each systems, the interfaces were configured.
• Involved in mapping between two or more interpretations of the HL7 standard to resolve data model or workflow issues between incompatible applications
• Reading a database and creating an HL7 message
• Highly involved in understanding of department workflows and process flows with respect to applications.
• Developed business process models in RUP to document existing and future business processes. Improved process for payment of Medicare Secondary Payer claims through revised workflows.
• Collected the information related to ongoing application upgrade and their impact on ICD-10 implementation and created awareness within the departments regarding the need, impact, benefits and risks of ICD-10 code application
• Re-Organized the collected data and prepared documentation for implementation.
• Involved in providing education about the ICD-10 codes and 5010 standards, its requirements, complexity and accuracy to Physicians and Nurses of the hospital.
• Figured out the requirement of training in various departments of the hospital based on their daily work
• Performed impact analysis on applications for deadliness of ICD-10 conversion.
• Responsible to meet the information demands of our business users by delivering timely, accurate, meaningful and standardized data and reporting
• Mapped the collected data with the existing data provided by the hospital departments
• Used Word, Excel and Visio as a working tool
• Hands-on experience and good understanding of the hospital working system including Registration, Scheduling, Radiology, Laboratory, Pharmacy, Patient Accounting, HIM, Claim Processing etc.
• Also involved in implementation of ARGUS drug safety system.
• Met the deadlines and scheduled day to day meeting sessions.

Confidential

Pharmacovigilance Associate

Responsibilities:

• Monitored the clinical safety of projects/products and responds appropriately
• Performed medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications.
• Identified safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked. Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools.
• Provided input into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues.
• Provided pharmacovigilance input to initial development of basic prescribing information and is responsible for pharmacovigilance input into updates of this information.
• Prepared medical input to aggregate clinical safety regulatory reports
• Provided input to safety profiling and risk management plan
• Provided guidance as appropriate to Clinical Safety Operations for the coding and causality or expectedness assessment of adverse event reports.
• Provided expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on drugs.
• Undergone evaluation and assessment of incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information.
• Coded all adverse event terminology, other medical information, and drug information in Pharmacovigilance database utilizing MedRA and WHO-DD dictionaries.
• Determined necessary follow-up for missing, discrepant or additional information or source documentation for each case using medical, product and regulatory knowledge and ensures that required follow-up for assigned cases has been completed
• Performed literature review of all applicable products and ensured required literature cases are processed within the Pharmacovigilance database
• Produced expedited and non-expedited individual case safety reports to regulatory authorities to ensure compliance with regulatory and company timelines.
• Assisted in the preparation of periodic and annual safety reports and investigator communications.
• Assisted in the development of Patient Safety Narratives for final Clinical Study Reports, in conjunction with the appropriate Medical Writing and Data Management personnel.
• Worked in risk assessments and signal detection activities for therapeutically aligned products and performed other duties as requested.

Confidential

Quality Assurance Associate

Responsibilities:

• Ensured departmental compliance with all operating compliance with all operating procedures, protocols, health & safety procedures and policies and any other instructions relevant to within any area of the company.
• Communicating with internal and external customers in relation to quality audits, projects and data whilst developing the effectiveness of your team
• Keeping up with the latest clinical data supplied by the company and interpreting, presenting and discussing this data with health professionals during presentations.
• Developing strategies for increasing opportunities to meet and talk to contacts in the medical and healthcare sector.
• Involved in Tablet Manufacturing such as weighing, mixing, blending, granulation and packaging
• Introduction to various functions in Capsule Manufacturing including filling, coating and packaging worked in Quality Assurance department
• Perform analysis of raw material, in-process and finished products, purified water, cleaning validation and stability samples using analytical instruments and established analytical procedures and techniques
• Recognizes OOS or out of trend results and under the direction of the Supervisor completes lab investigations.
• Performs general maintenance and calibration of laboratory equipment, according to the department's established calibration program.
• Provides technical troubleshooting support or training to other team members where appropriate.
• Ensures that all work is performed in compliance with GMPs, GLPs, SOPs and established regulatory requirements.
• Performed analysis of pharmaceutical raw materials, in-process and finished products as per USP, NF and In-house test method using Wet Chemistry technique and HPLC.
• Maintained detailed laboratory records in accordance with Standard Operating Procedures (SOP).

Confidential

Quality Assurance Associate

Responsibilities:

• Managing Quality compliance on site by ensuring that SOP's are relevant, effective and current
• Extensive experience in conducting self-inspection, vendor and GMP audits, conducting staff training and preparing for audits by the third parties and regulatory agencies.
• Ensuring that quality standards and requirements as defined by the Company's Quality System are maintained at all times.
• Responsible for all communication with the relevant regulatory authorities.
• Ensuring that there is a comprehensively designed and correctly implemented system of Quality
• Assurance incorporating Good Manufacturing Practice and thus Quality Control.
• Ensuring that the Quality Assurance system should be fully documented and its effectiveness monitored.
• Evaluation and final decisions regarding batch disposition
• Providing pharmaceutical support in decision making processes
• To assist and maintain aspects of the Quality Management System, adhering to SA GMP requirements and those of the Office of Global Quality.
• To provide support to the business by timeous review of products for release.
• To assist with Audits at Third Party Manufacturers and Laboratories to ensure this company’s standards are practiced.
• To assist with Quality Complaints Investigations.
• To review and authorize Stability results, Change Controls and Master Batch Documentation and reviewed into QA Databases.