Data Entry Clinical Research

JIBOLA D BASORUN

**** ****** ******, ******** ** 07205 (c) 973-***-**** ********@*****.***

Summary skills:

•Proficient in data entry using drug safety database ARGUS

•Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations

•Perform triage on incoming cases by assessing seriousness, expectedness, casualty and regulatory clock start date for FDA submissions

•Perform data entry into the safety database (word format) for initial or follow up cases from pre and post-marketed drugs.

•Create comprehensive and accurate narratives for both serious and non-serious cases procured from relevant, related information from various source documents.

•Apply knowledge on MeDRA coding for issuing queries for all discrepancies found while coding on situational case scenarios on following concept

•Knowledge of ICH-GCP, FDA and EMA guidelines

Professional experience:

Drug safety associate:12/2014-present

Clinical Research Academy of America-Edison, NJ

•Received, documented and processed adverse event (AE) reports from clinical trials and post-marketing in accordance with company Standard Operating Procedures (SOPs)

•Performed case Prioritization/Triaging based on seriousness of adverse events in accordance with SOP guidelines

•Performed manual coding of AEs using MeDRA dictionary for the events that were auto-encoded

•Participated in preparation of Periodic and aggregate safety reports

•Tabulated and formatted AE’s with Medwatch form for FDA regulatory reporting and familiar working with CIOMS form for EU regulatory reporting

•Perform data entry into the safety database for initial or follow up cases from pre and post marketed drugs.

•Performed case Prioritization/Triaging based on seriousness of adverse events in accordance with SOP guidelines

•Collected, documented and processed adverse event(AE) reports from various sources such as clinical trial, post marketing and Literature sources.

Shift lead: 10/2010-12/2014

Walgreens- Belleville, NJ

•Direct and supervise employees engaged in sales, inventory-taking, reconciling cash receipts, or in performing services for customers

•Monitor sales activities to ensure that customers receive satisfactory service and quality goods

•Inventory stock and reorder when inventory drops to a specific level

Pharmacy technician: 08/2009-10/2010

Walgreens- Belleville, NJ

•Prepack bulk medicines, fill bottles with prescribed medications, and type and affix labels

•Order, label and count stock of medications, chemicals, or supplies and enter inventory data into computer

•Receive written prescription or refill requests and verify that information is complete and accurate

•Answer telephones, responding to questions or requests.

Education:

•Drug safety associate and pharmacovigilance

Clinical Research Academy of America-Edison, NJ

•Bachelor of arts -2017

Essex county college- Newark, NJ

References:

Provided on request

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