Data Entry Customer Care

Pratyusha Veerasuri

Hyderabad, TS

*************@*****.***

Summary of Skills:

• Over 3 years’ experience as a drug safety Specialist which includes processing of spontaneous, clinical, literature cases and review, clinical narrative writing, quality compliance, quality assurance, and development and implementation of Global regulations/guidelines, Standard Operating Procedures (SOPs), and training materials.

• Therapeutic Area: Antiviral, Antipsychotic agents, Anti-diarrheal products, Respiratory and OTC products.

• Performed Triage, Data entry of ICSRs in the safety database, including determining the seriousness, expectedness of adverse events against various labeling documents (such as SMPC, CCDS, IB, USPI etc.), writing case summaries, assessing causalities and writing CIOMS comments if required.

• Involved in Pregnancy reporting process: Reporting of pregnancies to the sponsor, follow- up with the sites about the outcome and provide a regular update to the sponsor.

• MedDRA coding and accurate evaluations of serious events (causality, relatedness, expectedness, listedness) of adverse events (Serious and non-serious) and adverse drug reactions (serious and non-serious) for active trials and marketed products.

• Good understanding of FDA regulations, MHRA, GCP/ICH guidelines and IRB documentation.

• Submitted the expedited safety report (ESR) to applicable parties, which may include regulatory agencies, ethics committees and investigators. All submissions are tracked and submitted within regulatory timelines to ensure compliance.

• Comprehensive knowledge of international drug safety and Pharmacovigilance principles and regulations.

• Coordinated in project specific Safety Management Plan, reporting forms, further applicable project specific instructions and participated in study start-up and site training when applicable.

• In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements, and guidelines.

• Good verbal, written, interpersonal and communication skills to interact with users and team members, to understand and meet their business & functional requirements.

• Able to work well independently and within a team environment.

• Very good organizational and prioritization skills. Professional Experience:

Pharmacy Completion Analyst APR-2017 to Dec-2017

Medical Review Institute of America, West Valley, UT

• Evaluate opinions submitted by Reviewers upon conclusion of their reviews for compliance with company standards for completeness

• Follow-up with Reviewers whose submitted opinions do not meet all compliance standards

• Issue oral and written review outcome notifications that comply with standards and requirements for timeliness, content, recipients and accuracy including written notification grammar and spelling

• Bar code all materials received from Reviewers

• Research clients’ questions about review processes and/or Reviewer decisions

• Determine need for additional information or additional review and notify the client and internal departments of these needs

• Provide back-up support to staff in other areas as applicable

• Support all Quality Management initiatives

• Actively participate in the Complaint Process and Provider Relations Assessment process

• Support all Compliance Program activities

• Maintain or exceed the established monthly production & quality benchmark

• Participate in all company meetings and committees as requested Claims Specialist

Humana, Xerox Corporation, Sandy, UT JAN-2016-DEC-2016

• Worked as a Customer Service Specialist at Humana Pharmacy and Billing & Claim’s Project.

• Providing guidance to both external and internal customers. Comply with HIPAA and CMS regulations.

• Educating customers, providers and employers about Humana’s products and services over the phone as Prescription filling, Co-pay, Co-insurance, verifying CPT codes, coverage plans and benefits.

• Canceling or upgrading patient accounts.

• Assisted with placement of orders, refunds, or exchanges.

• Advised on company information and take payment information and other pertinent information such as addresses and phone numbers.

• Utilized computer technology to handle high call volumes.

• Worked with customer service manager to ensure proper customer service is being delivered.

• Close out or open call records.

• Compiled reports on overall customer satisfaction and read from scripts.

• Database used: Citrix, Argus, GCP, CI-Screen, and CMS. Associate Operation Specialist

Quintiles Technology, Bangalore, KA JAN-2013 to APR-2015

• Received and processed ICSRs from clinical trial and spontaneous reports.

• Triage and process Individual Case Safety Reports (ICSRs) to agreed internal and external timelines and procedures.

• Performed triage for seriousness, relatedness, and expectedness and prioritized incoming adverse events as per the protocol, investigator brochure, and/or labeling.

• Used MedDRA and WHO-DD in data entry, case processing and coding of serious adverse events received in compliance with SOPs and regulatory requirements.

• Involved in confirmation of initially entered data and follow-up information for ICSRs onto the Drug Safety database in accordance with the current Data Entry and Process Instructions and associated SOPs.

• Generated well-written, concise and accurate narratives for both serious and non-serious cases.

• Perform listedness by using CCDS, IB, SmPC and USPI

• Assisted in SAE reconciliation.

• Identified patient outcome and event type for the medical device adverse event cases

• Data base used: SCEPTRE

Awards & Recognition:

• Awarded “Star Performer of the Month” for the month of October in 2013.

• Awarded Star Award in August 2014. This quarterly award is designed for best Individual/Team Performers for achieving any outstanding performance.

• Honoured member of Alpha, Beta, Kappa (ABK).

Certifications:

• Completed PG diploma in Clinical Research, CDM, PV and SAS.

• Internship at Quintiles Pharmacovigilance Centre

• Acquainted with basic SAS programming.

• Registered Pharmacist in INDIA.

• Expert in MS-office

Educational Qualification:

• MS, master’s in health care administration, Stevens Henager College, Salt Lake City, Utah.

• Bachelor of Pharmacy, Khammam College of Pharmacy, Affiliated to Kakatiya University, India.

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