Safety Data Entry

Vineela Talluri

Drug Safety Specialist

Professional Summary:

• Experience in drug safety for over 4 years as a drug safety archivist, associate and specialist.

• Comprehensive knowledge of drug safety principles and regulations.

• In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements and guidelines.

• Expertise in reviewing, evaluation and summarizing the data – Case narration.

• Familiar with the regulatory rules, regulatory terminology and FDA guidelines

• Skilled in using databases Empirica and Argus.

• Familiar with basic computer applications – MS Office outlook, MS Excel, MS power point and MS SharePoint.

• Possess sound communication skill both in verbal and written and good prioritization and time management skills.

Education:

• Masters in Analytical chemistry, Governor’s state University, IL

• Bachelor of Science in Pharmacy, Osmania University, India

Work experience:

1) ICON Clinical Research Institute, PA

Sep2010–Feb2011 Drug Safety Associate

• Processing of adverse events (Triage process) data for

investigational and spontaneous AE reports.

• Recording of questions, adverse events and complaints from consumers and reporters.

• Reviewing, evaluating and summarizing information in a written document and initiating investigations if required.

• Creating of new cases, searching for duplicate cases and extract information from the database.

• Generating of the case narratives and coding of events in MedDRA, and generation of Medwatch.

• Using internet or electronic databases to mail the inquiries and appropriately respond and to search for the published literature on the company products.

• Adverse event report processing (for pre and post marketed studies) within 24 hour limitation to meet with the regulatory requirements for FDA and ICH guidelines etc.

2) Hetero Research Institute, India

Jun 2009 – Aug 2010 Drug Safety Associate

• Initial safety review, identification and follow –up review of serious adverse events (SAEs)

• Generating of case narrations of the reported SAEs and AEs for CSR

• Assisting in development of guidelines and procedures pertaining to the safety department

• Preparing and maintaining weekly activity logs

• Assist in the generation and distribution of IND safety reports

• Preparation and distribution of Dear investigator letter: sending weekly DIL notification to team members, reconciliation of DIL for submissions and sending monthly DIL report

3) Indu Clinical Research Organization, India

Apr 2007- May 2009

Junior Drug Safety Associate

• Monitoring and tracking of adverse events.

• Data entry of the SAEs into the safety database.

• Assisting in case narrations.

• Filing, maintenance and distribution of SAEs to team members.

• Locating and retrieving of archived documents when requested.

• CRF tracking and validation for authenticity during scanning.

• Maintaining a tracker for incoming SAEs and archiving patient records.

• Assisting in preparing and reviewing safety reports.

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