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Data Entry Safety

Mississauga, Ontario, Canada
February 15, 2018

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*+ Yrs Experienced Drug Safety Associate (Pharmacovigilance)

****-**** ********** ****, ***********, ON, Canada, L5B 0G2


Profile Summary:

A Pharmacovigilance associate with 4 Years of intense experience in the fields of Drug Safety and PV principles and regulations.

Brings onto the table vast knowledge of Drug Safety and development processes and procedures, alongside coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines.

Skill Set:

In-depth knowledge of

coding principles,

submission criteria,

regulatory timeline requirements,

technical requirements,

GCP Guidelines,

Work Experience:

June 2015 – Oct 2017: - Global Safety & Pharmacovigilance Associate I @ inVentiv International Pharma Services Pvt. Ltd

June 2013 – June 2015: - Process Analyst @Accenture Services Pvt Ltd.

Academic Record:

Rajiv Gandhi University of Health Sciences

2012: Master of Pharmacy (Pharmaceutics)

2010: Bachelor of Pharmacy

Roles and Responsibilities:

Processing and evaluation of Serious Adverse Events / Post Marketing Adverse Events to ensure accurate and consistent data entry and processing from articles, with emphasis on timeliness and quality.

Ensure accurate and consistent coding of medical history, drugs and adverse event terms.

Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling.

Screen literature articles for data basing or rejection.

Responsible for screening title, abstract and full text publication and identifying the relevant passages or sections in the publication that describes an adverse event and a client specific Pharma product.

Identification of one or more valid ICSR qualifying for data entry into the Argus safety database and ensuring that the articles rejected do not contain valid ICSRs, per the guidelines.

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