Data Entry Safety

Saroj Verma

*** ********* ***, *** *, Jersey City, NJ - 07307, USA Mobile: 201-***-**** Email: ******@*****.***

Professional Summary

Senior Process Associate knowledgeable in creating reports from post marketing surveillance, and well-informed in drug safety related database and software.

Highlights

Experience in reporting Post marketing events in Pharmaceutical Industry

Adept knowledge of US and ICH safety reporting regulation and guidelines

Remarkable Knowledge to monitor and track Serious adverse events, Serious and non-serious adverse drug reaction and other medically related project information

Comfortable in handling and documenting client communication

Proficient in data entry and drug safety database (Argus)

Knowledge of event and drug coding using MedDRA and WHO-DD

Experience in conducting CAPA training

Knowledge of drug development

Experience in writing safety summaries

Knowledgeable in FTIR, UV-VIS spectroscopy, Karl Fischer water determination

Knowledgeable in HPLC, TLC chromatographic instrumentation

Professional Experience

Senior Process Associate in Pharmacovigilance Apr 2014 to May 2016

Tata Consultancy Services –Mumbai, India

Performed initial evaluation of spontaneously reported serious and non-serious adverse events case reports including reports from post-marketed surveillance studies.

Performed data entry of serious and non-serious adverse events of spontaneous reports including reports from non-interventional source, legal documents, AOL, IRMS.

Performed case assessments like reviewed events, determined expectedness, listedness, causality, and seriousness.

Performed data entry, routing, follow-up, and timely reporting/submission of safety information related to drug products from a variety of sources.

Inserted the consumer reported information in a central repository (Argus) on the basis of individual case histories.

Performed quality control activities to ensure complete and accurate case information.

Adhered to Global reporting rules including FDA, ICH etc.

Registered Pharmacist Mar 2013 – Oct 2013

Retail pharmacy –Mumbai, India

Assisted other pharmacists with drug inventory, purchasing, and receiving.

Complied with all federal laws, company policies and procedures and state regulations.

Inspected drug storage sites, monitored drug supply expiration dates and ensured proper supply levels.

Receptively answered customer questions and helped locate desired items in the pharmacy.

Translated pharmacy communications for native speaking customers nationwide.

Analytical Research and Development Trainee Jun 2011-Nov 2011

Microlabs Pvt. Ltd–Mumbai, India

Used analytical instrument such as HPLC, FTIR Spectrophotometer, UV Spectrophotometer, Dissolution apparatus, and Particle size analyzer, Karl-fischer Titrimetry, Differential Scanning Calorimetry.

Performed Validation of Assay, Dissolution and Particle size Determination.

Performed various tests such as Assay, Dissolution, CDP, Pre-formulation studies and related substances.

Education

Master of Pharmacy 2010 – 2012 School of Pharmacy and Technology Management, NMIMS, Mumbai, India

Bachelor in Pharmacy 2007 – 2010

Mumbai University, India

Academic Projects

Development and validation of Analytical Method for Assay Of An Antibacterial Drug by RP-HPLC.

Formulation of Pulsatile Drug Delivery System Containing Ibuprofen And Famotidine.

License

Registered Pharmacist in India

Skills

Microsoft Excel, PowerPoint, Word, Argus.

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