Clinical Research Data Entry

Mittu Mathew

Drug Safety Associate

804-***-**** ***************@*****.*** Richmond VA 23116 www.linkedin.com/in/mittumathew Objective

To grow professionally and personally in the field of clinical research, while taking up challenges that will progress me towards my goals.

Skills & Abilities

Oracle Argus safety (8.2.3 version), Med DRA coding, AERS, WHODD, ICH/GCP guidelines and procedures, FDA regulations, GVP guidelines.

Work history

Aesthetic Dental Clinic, Kerala, India (Junior Dentist)

Educating patients on their oral hygiene and dental care

Examining patients teeth and diagnosing potential dental problems, if any

Perform dental treatments such as filling, teeth extractions, root canal treatments

12/2009 – 08/2010

Quintiles Research, Bangalore, India (Associate Operations Specialist)

Responsible for coordinating and performing adverse event (SAE/AE) reporting, review entered cases for quality.

Contributed and worked for special study team (cancer) project for Merck.

Responsible for Intake of cases and create cases after performing duplicate search and add follow up to the existing cases in ARGUS safety database

Triage/prioritize cases for data entry of post marketed serious and/or non- serious individual case safety reports into Oracle Argus safety database.

Coding of suspect drugs, concomitant drugs, treatment drugs and previously prescribed drugs using WHO drug dictionary.

Prepare medical narratives and assign MedDRA terms to adverse events, submission of CIOMS/MedWatch forms and serious cases to regulatory authorities including FDA and EU.

Ensure that ICSRs reports received from various sources, including clinical trials, spontaneous reports, and literature are submitted in the client database within agreed timelines, update causality assessment and narratives, liaising with client, execute case closure and reconciliation. 1/2014 – 5/2015

Took a career break to start a family, moved to US 6/2015 - present

2

Sollers College, Piscataway, NJ (Data Safety – Intern)

Perform data entry of ICSRs and conduct case processing activity for adverse events using Oracle Argus Safety.

Follow ICH/GCP, US FDA guidelines and timelines for safety reporting.

Hands on training in Aggregate reporting which includes extraction of NDA listing from ARGUS Safety for PADER preparation, ICH Line listing for PSUR/PBRER line listing and Case Data Analysis.

Extraction of case listing for Aggregate reporting purposes. 2/15/2024 - present

Education

Vinayaka Mission Sankarachariyar Dental College, Salem, India

After 4 years of BDS, was on a 12 months internship in departments of Oral Surgery, Oral Medicine, Periodontology, Conservative Dentistry, Prosthodontics, Pedodontics, Orthodontics and Public Health Centers.

Participated in various dental camps, public awareness programs and other voluntary causes.

Regular participant of seminars and Continuing Dental Education programs during my academic tenure

Bachelor of Dental Surgery

(BDS)

8/2004 -8/2008

Lotus Clinical Research Academy, Bangalore, India

Was deputed as Industrial Trainee in Clinical Data Management with Norwich Clinical Services during this time

Certificate course on

clinical research,

pharmacovigilance and

clinical data management

8/2013 – 01/2014

Sollers College, Piscataway, NJ

Currently pursuing Advanced Drug Safety and pharmacovigilance course at Sollers College.

Advanced Drug Safety and

pharmacovigilance course

at Sollers college

3/2023 – 9/2023

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