EXPERIENCE SUMMARY

I have a total experience of 4.7 years of experience in Software Testing for Assurance and Healthcare domain (with Top 5 Pharmaceutical companies) .I am an associate with Confidential and currently involved in a Software testing project as Systems Engineer with one of the leader in pharmaceuticals based in US.

TECHNOLOGY

Below is a list of important software products, tools and methods that I have worked with.

Operating Systems : Windows 98/2000/XP

Databases: MS SQL Server 2005, MS - SQL

Languages: Java, C, cgi-perl,sql, pl-sql

Software: ARISg6.6, Argus, Agxchange 6.6, Quality Center 11

Tools: Quality Centre 11, Oracle clinical Customer Safety database, Microsoft Office, Citrix, IBM Rational DOORS, Microsoft Excel sheet

PROFESSIONAL EXPERIENCE

Confidential

Description: Client is one of the world's 20 leading pharmaceutical companies. It operates globally with 145 affiliates and more than 42,000 employees. The company’s key assets of interest are: respiratory disease, cardiovascular disease, Parkinson's disease, HIV, thromboembolic disease and cerebrovascular disease. Client is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Role: Team Member - Support Analyst

Responsibilities

The responsibilities involve the following:

• Providing business support to Business users.

• Providing Business Support for application being used by Customer

Solution Environment: Windows XP

Tools: BI Service Manager, IBM Rational DOORS,CITRIX, ARISg 6.3, Validation tool

Confidential

Description: Provide technical and process-related expertise to Drug safety and Pharmacovigilance activities, ensuring compliance with applicable regulations and Standard Operating Procedures (SOPs).

Role: Team Member - Senior Analyst

Responsibilities

• Manual recoding of medicinal product information contained in the ICSR s, data validation and cleaning of medicinal product information in the EVMPD, quality control of ICSRs and translation of case narratives in ICSRs.

• Assume Senior Analyst role to delegate project related tasks among the team and determines team membership to achieve company’s business goals .
• Performing quality check of regulatory individual case safety reports after submission to the regulatory agency
• Actively involved in discussions and training meetings

Solution Environment: Windows XP

Tools: EudraVigilance (EU) database

Confidential

Description: Provide technical and process-related expertise to Drug safety and Pharmacovigilance activities, ensuring compliance with applicable regulations and Standard Operating Procedures (SOPs).

Team Member - Safety Processing Expert

Responsibilities

• R eceive information on adverse events, perform initial checks, search database to prevent du-plicate entries, create case file and initialize received drug safety reports in the IMS (Integrated Medical Safety) tracking tool and/or safety database (Argus Safety).

• Processing of Clinical trials, Sponataneous, Solicited PMS, Licensee exchange partner. Regulatory Authority cases.
• Ensure scientific rigor through accurate, complete and consistent data entry of Adverse Event reports from source documents with emphasis on timeliness and quality
• Use medical dictionaries and business guidance’s to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case
• Causality Assessment and Case Triaging
• Initiation of cases from triaging to ARGUS
• Alert manager to potential safety signals based on incoming case reports
• Assist with related administrative and procedural activities as required or requested

Solution Environment: Windows XP

Tools: ARGUS, SINA

Confidential

Description: Process medium (100 to 200 adverse effects (AEs)) to large (over 300 AEs) and/or global clinical safety or post marketing cases ensuring all activities are completed on-time, and meet quality standards.

Associate Pharmacovigilance Specialist

Responsibilities

• Managing spontaneous and clinical trial adverse event reports

• Tracking and reviewing of SAE reports for consistency and accuracy, preparing SAE narratives
• Data entry of clinical trials and postmarketing events into safety database ARISg
• Reporting serious adverse events to regulatory authorities and sites participating into in the studies
• Receive and document incoming telephone calls or faxes from investigative sites or other sources reporting AEs, serious adverse events (SAEs) and spontaneous events; collect, track required data and enter into safety database, if applicable; follow up with sites to obtain missing data as required.
• Process data according to applicable regulations and guidelines, SOPs, and project requirements
• Raise queries to Investigator and Data management for missing information
• Use OCRDC to check the adverse and other data
• To identify SUSARs and fulfil regulatory reporting requirements for SUSAR reporting to the MHRA and Ethics Committees
• Create complete, accurate and succinct narratives adhering to established project template. Establish and maintain a thorough understanding of project protocol, budget and scope of work (SOW) for assigned projects set up and maintain project materials such as project files, forms, templates, databases and workflow

Solution Environment: Operating System - Windows XP

Tools: ARISg

Confidential

Description: Possess an in-depth understanding of spontaneous, clinical trial, literature and its safety reporting system for processing of cases. Hands on experience in signal detection, coding, case triaging, narrative writing and single case assessment (SCA).

Drug Safety Associate

Responsibilities

• Managing spontaneous and clinical trial adverse event reports

• Triage of incoming cases to determine seriousness for prioritization of daily workflow.
• Confirmation of previously entered data and completion of data entry, including writing adverse event case narrative;
• Assess expectedness of adverse events and code approval numbers
• Complete quality review of own or peer DSA case executing literature searches to identify adverse events for inclusion in the worldwide safety database
• Follow procedures for supporting activities, such as requesting deletions, addition of new codelist terms, preparing deviation memos etc
• Understand safety implications regarding contracts with the clients marketing partners
• Performing the Literature searches through in various journal and databases.

Solution Environment: Operating System - Windows XP

Tools: SCEPTRE (Oracle based Customer Safety database)

Confidential

Description: Confidential is a database that is being developed by Simbiosys as a comprehensive resource for drug discovery and development related information on metabolic diseases specifically diabetes and obesity the database contains information related to SNP analysis, gene expression, epidemiology, animal models, disease association.

Database curation and Data Management

Responsibilities

• Performing the database curation through various online databases

Solution Environment: Windows XP, Linux

Designing Database Frontend

Description: Confidential is a database that is being developed by Simbiosys as a comprehensive resource for drug discovery and development related information on metabolic diseases specifically diabetes and obesity the database contains information related to SNP analysis, gene expression, epidemiology, animal models, disease association.

Responsibilities

• Designing database frontend

Solution Environment: Operating System - Windows XP

Tools: cgi-perl, MS-SQL and SQL