Data Entry Safety,ICSR, ARISg data base
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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