SUMMARY:

• Experienced health professional with graduate degrees in clinical medicine and public health.
• Over 10 years of experience in patient care and analyzing clinical and research interventional data and monitoring patients for treatment efficacies.
• Capable of planning, conducting, and analyzing research interventional data, and evaluating results.
• Experienced in patient care and clinical research focused on adverse event reporting on investigational and post - marketed drugs.
• Trained in pharmacovigilance and working with global safety databases. Works well in a challenging, fast-faced environment independently as well as part of a diverse team.
• Excellent leadership and interpersonal skills.
• Experienced in data analytics and management
• Reviews and coordinates with investigative team to determine the root cause of complaints
• Collaborated with the quality department to assess root causes of complaints and formulated action plans to prevent future occurrence
• Experienced in Oracle Argus Drug Safety database (Version 8.1) and MedDRA (Version 19.0)
• Understanding of ICH-GCP, HIPAA guidelines, FDA regulations, regulatory submissions, and Good Pharmacovigilance Practice Guidelines (GVP)
• Knowledge of 21 Code of Federal Regulation parts 11, 50, 54, 56, 312, 211, 803, 820
• Capable of Serious Adverse Event (SAE) reporting and Individual Case Safety Reporting (ICSR)
• Knowledge of statistics and statistical methods; strong command of Good Laboratory Practice (GLP) regulations
• Knowledge of computerized databases for the maintenance of scientific data
• Proficient in MS Office, SPSS and analytical tools
• Experience maintaining SharePoint
• Working knowledge of REMS (Risk Evaluation and Mitigation Strategies) to ensure that the benefits of drugs and biological products outweigh the risks
• Working knowledge of statistics and statistical methods and handling SQL queries
• Working knowledge of MATLAB/Simulink
• Strong team player with excellent oral and written communication and problem-solving skills

PROFESSIONAL EXPERIENCE:

Confidential

Clinical Coordinator/Data Analyst/Business Analyst, Adrian, Michigan

Responsibilities:

• Ensuring collection, integration, management, and availability of clinical data
• Gathered the business requirements and prepared the analyzed data/workflows for business users.
• Analyzed business needs and created Business Requirement Document (BRD), Application Use Case (AUC) documents for business and end user review.
• Analyzing clinical data using Excel functions (spreadsheets, writing formulas, V-lookups, pivot tables, macros, etc.)
• Looking at data sets as a whole and analyzing for trends as well as discrepancies, outliers, and possible errors
• Worked in teams using Agile values and methodology
• Experience in conducting and facilitating JAD sessions for project definition involving analyzing requirements, creating prototypes, and user interface documents.
• Conducting database searches
• Making sure data aligns with clinical picture
• Developing and implementing strategies to improve treatment outcomes and prevent medication and hospital related errors for patients in long-term healthcare facilities
• Preparing reports, statistical comparisons, data charts, and other presentation materials
• Designed strategies for nosocomial infection prevention illustrated with: root cause analysis, flowchart, fishbone diagram, and Gantt chart
• Ensuring good clinical practice to preserve privacy and security and protection against fraud and potential liability
• Maintaining SharePoint
• Responsible for overseeing patient care and optimizing each patient’s needs with appropriate services
• Communicating with patients to assess their needs and match them with the best provider
• Developing plans to provide targeted care to special needs and vulnerable populations
• Using performance improvement tools such as HEDIS to identify any gaps in performance and address opportunities for improvement, monitor the success of quality improvement initiatives, track improvement, and provide a set of measurement standards that allow comparison with other plans.
• Devising quality improvement plans that are realistic and easy to comply with
• Maintaining and updating patient records
• Improving businesses practices and handling budgets
• Working with the complaint team to ensure HIPAA guidelines and compliance
• Triaging patients in different clinical settings and monitoring them closely for adverse drug events and treatment efficacies
• Working with clinical teams in the diagnosis, management, and treatment of various acute and chronic disease states including diabetes, hypertension, blood, and endocrine and rheumatological diseases
• Patient on management of diabetes and antihypertensive medications including how they work, how to use them, and side effects
• Patient on how to perform in vitro diagnostic tests (self-testing) for pregnancy (urine test) and how to use blood sugar monitoring devices and insulin pumps
• Performing literature searches, preparing case narratives, and collaborating with the clinical team to maximize therapeutic outcomes
• Mentoring colleagues as well as providing patient counseling and on treatment plans

Confidential

Advanced Drug Safety Professional, NJ

Responsibilities:

• Performing case processing activities for adverse events from receipt to case closure in accordance with ICH-GCP and USFDA regulatory guidelines
• Focused on initial case assessment to determine validity and triaging cases to prioritize seriousness and expectedness/listedness
• Conducting database searches to eliminate duplicate entries prior to case initiation/book-in
• Data entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Argus Safety Database and performing quality check of ICSRs
• Writing case summaries of gathered information into a concise clinical narrative, assessing causality, and writing CIOMS comments if required
• Coding adverse events and drugs using MedDRA and WHO Drug Dictionary
• Generating queries to obtain missing case information and clarifications if required in Electronic Data Capture (EDC)
• Tracking queries in Excel
• Ensuring that follow-up requests for assigned cases have been completed
• Determining that the case meets expedited reporting criteria
• Performing quality review for adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs)
• Assisting with AE/SAE reconciliation prior to database closure
• Collaborating with pharmacovigilance physicians to facilitate the review of SAEs and ensure medical accuracy and quality
• Performing literature searches
• Assisting with ensuring that periodic and expedited safety reports comply to both internal and regulatory timelines with strong knowledge of periodic reporting including PADER/DSUR/PSUR/PBRER

Confidential

Healthcare Business Analyst/Data Analyst, Columbia, MD

Responsibilities:

• Researched and analyzed NQF and CMS measure data to ensure quality improvement and pay-for-reporting programs for specific healthcare providers
• Responsible for research, data collection, public reporting, rule writing, and business analysis according to the provisions of the 2010 Affordable Care Act (ACA)
• Wrote and updated existing SOPs for the Post-Acute Care Project with the team
• Delivered supporting documentation, created and mapped spreadsheets, and performed peer reviews to ensure the client’s business requirements were satisfied and were in adherence with strict CMS timelines
• Responsible for creation of requirements for the Oncology Care Medical Registry (OCMR)
• Worked with teams using Agile development methodologies
• Prepared meeting agenda and minutes gathering requirements in client meetings and finalized requirements document upon receipt of feedback with client
• Maintaining SharePoint
• Created test scenarios and test plans and drove UAT (user acceptance testing) in development and validation environments for the team

Confidential, Chicago, IL

Research Intern

Responsibilities:

• Designed a model for the study resulting in a base model for future studies
• Analyzed and improved the model resulting in a 70% reduction of time spent on data collection
• Developed interventions to study and improve South Asian heart health in the US
• Developed and field-tested research protocol in compliance with Institutional Review Board (IRB) guidelines
• Applied data gathering tools such as questionnaires, Fitbit, and interviews to periodically measure and track participant activities
• Facilitated as a liaison across cross-cultural participants to promote health and counsel them
• Documented biometric data and prepared health charts to analyze the impact of the study
• Utilized Excel on a daily basis for large data sets

Confidential, Adrian, MI

Primary Care Clinical Extern

Responsibilities:

• Performed history and physical examinations and triaged patients in the general medical floor and primary care outpatient clinic
• Collected demographic, diagnostic, and therapeutic data
• Helped formulate diagnostic and treatment plans
• Educated patients about indications and major adverse effects of various medications in acute and chronic diseases and counselled them on disease management
• Followed up with patients over time after introduction of new drugs for efficacy for side effects and adverse events

Confidential, Chicago, IL

Rotating Extern

Responsibilities:

• Worked in clinical teams in medical and surgical specialties to diagnose and manage patients
• Rotated in the departments of general surgery, internal medicine, obstetrics and gynecology, pediatrics, psychiatry, ENT, ophthalmology, emergency medicine, and intensive care
• Managed patients with various disease states including rheumatologic, autoimmune and neoplastic conditions
• Compiled medical reports such as history and physicals, patient progress notes, consults
• Gathered missing information for case-related documents and prepared detailed reports for hospital teams
• Counseled patients under medical treatment plans