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Data Entry Safety,ICSR, ARISg data base

Location:
Fremont, CA
Posted:
March 26, 2018

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Resume:

Divya Vallapu

Summary:

● Result oriented Drug safety associate with experience in Individual Case Safety Reports and safety databases.

● Managed activities related to collecting, processing, follow-up, analysis regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products.

● Performed quality control (QC) checks for data entered for ICSR reports from both investigational and post marketing products and ensured accuracy and compliance with conventions and regulatory standards.

● Processed Individual Case Safety Reports (ICSRs), including data entry in MARG safety database.

● Documented new product information and improvements in the existing combination as per the current market activities and competitors

● Excellent communications skills, outstanding organizational skills, detail oriented, team player, high integrity and possess the ability to multi-task and handle highly confidential information. Performed well with little supervision as well as prioritizing tasks effectively. Skills

● SOPs and other GMP documents

● MS Office, MS word, MS Excel

● ICSR reports

● ARIS Database

● MARG Database

Education

● Master of Science in Pharmacy (Pharmaceutical Analysis) Sept 2012 - Nov 2014 JNTU, Hyderabad, India.

● Bachelor in Pharmacy. Oct 2007- April 2011

JNTU, Hyderabad, India.

Professional Experience

Drug Safety Associate I (DSA 1) A ug, 2017- Nov, 2017 Genentech, South San Francisco, CA

● Drug safety monitoring and tracking in a timely, in accordance with Pharmacovigilance

(PV) related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs).

● Performed data entry of adverse event case data through the receipt of local AE reports received from healthcare professionals or consumers.

● Assisted in the timely completion of AEs to submit to Roche global via the ARIS suite.

● Performed the review of ancillary documentation accompanying Individual Case Safety Reports (ICSRs) for incorporation into the Global Safety Database.

● Maintained and updated documents and trackers related to safety reporting as required.

● Provided support to projects as assigned by and under the direction of the US Drug Safety Case Manager .

GVR Pharma J an 2014 - Oct 2016

Drug safety Associate

● Managed activities related to collecting, processing, follow-up, analysis regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products.

● Clinical pharmacovigilance regulations(PV) - Performed initial triage of the safety notifications received, follow-up ICSRs with the reporter, generate follow up (FU) queries and send FU requests.

● Processed Individual Case Safety Reports (ICSRs), including data entry in MARG safety database.

● Basic knowledge creating charts and graphs for trending using MS Office, MS word, MS Excel.

● Performed quality control (QC) checks for data entered for ICSR reports from both investigational and post marketing products and ensured accuracy and compliance with conventions and regulatory standards.

● Developed Drug promotional materials such as visual aids, literatures and catch covers.

● Received, performed composition Analysis and Forwarded orders to billing departments with Instructions for pharmaceutical product orders form stockist all over India.

● Documented new product information and improvements in the existing combination as per the current market activities and competitors.

● Accomplished individual targets timely, and contributed for team success. Madhav Biotech Sep 2011 - Dec 2013

Quality Assurance Associate

● Planned Production orders and maintained inventory of finished drugs.

● Purchased raw materials and in process materials for Drug Production.

● Worked on documentation for Licensure Application to the Drug department.

● Monitored and documented the movement of newly Promoted Drugs.

● Performed Audits on Drug labels as per NPPA (National Pharmaceutical Pricing Authority) norms.

● Worked under good manufacturing practices (cGMP) and International Organization for Standardization (ISO)

● Reviewed documentations including batch manufacturing record (BMR) sheets and standard operating procedures (SOP)

● Performed variety of inspections in process and finished products, packaging, printing, labeling, editing, reviewed, change control and proofreading of labels, numbering, and coding.

● Inspected and cleared finally finished packaging materials from packing line.

● Maintained packing material test documentation as per specifications of WHO GMP, USFDA and ICH guidelines.

● Performed QA document control function, including document login, tracking, processing, approval, distributing, and archiving in compliance to internal and external requirements of tablets, capsules and syrups.

● Coordinated the revision, review, and approval of SOPs and other GMP documents.

● Organized and ensured accurate and reliable filing systems for the paper-based GMP documents.

● Maintained and facilitates training programs including training matrix, training files, and annual audit of training files

● Processed and provided timely and accurate update of stability studies.

● Reviews quality outputs, change control, validation and qualification documents.

● Maintained change control and deviation processes for SOPs, master batch records, specifications, test methods, validation protocols/reports, technical protocols/reports, and other GMP documents

● Generated Incident Reports, Change Controls and CAPA reports, including reviewing adequacy of root cause, corrections, corrective actions, preventive actions and effectiveness.

● Updated and maintains Quality Assurance Operations logs and databases and generating metrics as needed.

● Participated in internal audits and supporting external audits CitraGen Pharmaceuticals, Inc., Fremont, California May 2017 –July 2017 QC/QA Chemist

● Prepared and handled Lab samples such as raw materials, In-Process samples and Finished products using Analytical instruments.

● Performed preventive maintenance, calibrations and troubleshooting of Analytical instruments.

● Documented and reported results as per established SOP’s.

● Participated in SOP review/revision process.

● Assisted in preparing purchase request for laboratory supplies.

● Strong working knowledge on UV, HPLC, Dissolutions and KF coulometer.



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