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Akhilesh Chaurasiya

B.Pharma & MBA Bioscience with 3 + year of experience in pharmcovigilance-2 Last Updated: January 1, 2017 (about 1 year ago)
  • Handling ArisG 5.3 and Argus 5.2 safety database for reporting adverse event.
    Received information on ensuring scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents.
    Identifying safety relevant publications and evaluating individual case safety reports (ICSRs) of adverse drug reactions from the published literature
    Coding and Narrative writing using MedDRA and WHO Drug
    Case receipt, triaging and processing of litigation cases, literature cases, and clinical trial.
    Comparing adverse events to adverse events previously reported and contained in the product label.
    Identifying and evaluating individual case safety reports (icsrs) of adverse drug reactions from the published literature
    Scanning the literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
    To contact, as required, UK / US office(s) and customers/clients in order to achieve required outcomes and meet timelines and other duties as assigned by management
    SAE processing & tracking, using tracking databases meeting the regulatory timelines.
    Review and reconciliation of safety and adverse event data obtained during the different phases of clinical Trials and the post-marketing phase.
    Responsible for triaging, processing, and narrative writing solicited cases, spontaneous cases, literature cases, and clinical trial cases. Follow-up of serious and non-serious cases.
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UAE
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Education

Pravara University MBA Master of Business Administration (Bioscience)
Jun 2010 — Jul 2012
Completed Master of Business Administration (Bioscience) from Pravara University
SMBT College of pharmacy Bachelor of Pharmacy from University of Pune
Mar 2005 — May 2010
Completed Bachelor of Pharmacy in 2010 From University of Pune

Experience

APCER Life Sciences Senior Pharmacovigilance Associate
Nov 2016 — Current
 Identifying and evaluating individual case safety reports (icsrs) of adverse drug reactions from the published literature
 Scanning the literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
 Detailed evaluation of individual case reports e.g. Determining seriousness of adverse events, determination of drug causality, subsuming signs and symptoms into clinical diagnoses etc.
 Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities
 Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (aes) from post marketing sources for completeness and regulatory compliance
 Prepare safety data reports for submissions to clients
 Prepare expedited Safety Reports for submission to Regulatory Authorities
 Assist in representation of Global Safety and Pharmacovigilance group at project team and client meetings
 Communicate with Clinical Operations and clients to ensure compliance with safety and pharmacovigilance sops
 Assist in compilation of regulatory submissions, i.e., Annual Reports, Periodic
 Safety Update Reports
 Assist the safety fead for projects; to include set-up, project management, client liaison
 Perform literature searches
 Assist with SAE reconclliation
 Creation, review and submission of icsrs/CIOMS-I forms.
 Single case management with regard to adverse drug reaction reports arising from clinical trials, spontaneous reports or literature, expedited and non-expedited reporting of adverse drug reactions.
 Writing and review of scientific and medical reports.
 Preparation and review of Clinical Expert Statements.
 Communication with regulatory authorities.
 Provision of medical advice to client companies with regard to all pharmacovigilance-focused aspects.
 Safety and benefit-risk evaluations for assigned products
Cognizant Technology Solutions Data analyst
Apr 2015 — Nov 2016
 Received information on ensuring scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents.

 Handling ArisG 5.3 safety database for reporting adverse event.

 Identifying safety relevant publications and evaluating individual case safety reports (ICSRs) of adverse drug reactions from the published literature
 Coding and Narrative writing using MedDRA and WHO Drug Dictionary.

 Case receipt, triaging and processing of litigation cases, literature cases, and clinical trial.

 Comparing adverse events to adverse events previously reported and contained in the product label.

 Scanning the literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
 Detailed evaluation of individual case reports e.g. determining seriousness of adverse events, determination of drug causality, subsuming signs and symptoms into clinical diagnoses etc.
 Coding and Narrative writing using MedDRA and WHO Drug Dictionary.

 Comparing adverse events to adverse events previously reported and contained in the product label
 Monitoring the workflow of the case, completing the case by prioritizing with SLA, and sending the status workflow status to the supervisors.
 Quality review of literature and review and summary of large safety data sets and presentation of results in draft reports.
 Familiarity with the reporting and regulatory requirements.
 Release report to client through client safety database
Sciformix Technologies Private Limited Jr. Safety data analyst
May 2013 — Mar 2015
 Data entry and quality check of ICSRs in pharmacovigilance database Argus 5.2
 Responsible for triaging, processing, and narrative writing solicited cases, spontaneous cases, literature cases, and clinical trial cases. Follow-up of serious and non-serious cases.
 Case Initiation: Identify duplicate cases, enter basic data into database, create tracking number and acknowledge receipt of case to sender.
 Data Entry: Identify duplicate cases, enter basic data into database, create tracking number and acknowledge receipt of case to sender.
 Case Inactivation: Determine whether case should be inactivated (whole case is invalid) or if follow-up report should be deleted because it is invalid.
 To contact, as required, UK / US office(s) and customers/clients in order to achieve required outcomes and meet timelines and other duties as assigned by management
 SAE processing & tracking, using tracking databases meeting the regulatory timelines.
 Review and reconciliation of safety and adverse event data obtained during the different phases of clinical Trials and the post-marketing phase

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