Mittu Mathew

Drug Safety Associate

804-***-**** ad193r@r.postjobfree.com Richmond VA 23233 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

Argus, MedDRA, AERS, ICH/GCP (E6) guidelines and procedures 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.

Triage data entry of post marketed serious and/or non-serious individual case safety reports into adverse event 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 reports are submitted in the client database within agreed timelines, update narratives, liaising with client, execute case closure and reconciliation.

1/2014 – 5/2015

Home Maker

Took a break from work to start a family and parenting. Moved to US during this time. I am trying to get back to working in pharmacovigilance & drug safety area.

During this time I have volunteered at the local church, cultural associations and elementary schools and also prepared for the US National Board Dental Examination.

Kept myself updated by reading Cobert’s Manual of Drug Safety and Pharmacovigilance and online journals like International Journal of Pharmacovigilance

6/2015 - present

2

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 – 7/2023

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