Description
SUMMARY * Pharmacovigilance Associate with over 2+ years of experience in Drug Safety and Clinical practice fields with clear understanding of EDC (Electronic Data Capture) * Experience in performing successful data management, triage, case entry, MedDRA, WHOdrug dictionaries, narrative writing, peer review, case follow-up, case review and report preparation * Performing Data entry and Quality check adverse event reports from Spontaneous, Marketing, Literature, Non-Interventional and Clinical trial sources * Processed safety reports from all sources for assigned products according to ICH-GCP and FDA guidelines. * Knowledge of safety risk management evaluation and safety data signal queries as and when required * Comprehensive knowledge of drug safety and drug development process and procedures. * Ability to apply sound analytical thinking and database query skills to gather, summarize, and evaluate critical information. * Team Player and also can work independently as required with very good organizational and prioritization skills. * Good oral and written communicational skills. * Proficiency with standard office skills, standard desktop computing programs, basic computer service principles and relational databases. * Knowledge of the procedures, processes and standards governing clinical trials (data and documents) with health authorities worldwide, and experience of following these within the defined business area
Work Experience
COMPANY | POSITION HELD | DATES WORKED |
---|---|---|
Acadia Pharmaceuticals | Drug Safety Associate | 5/2015 - 10/2017 |
Kamineni Multispecialty Hospitals | Medical Doctor | 1/2012 - 12/2013 |
Mediciti Hospitals | Medical Doctor | 5/2011 - 5/2013 |