Experience

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  Iqvia india

  Jan 2013 - Oct 2015

  Drug safety associate

   Hands-on experience in end-to-end case processing, clinical trial and post marketed ICSR activities which including triage, data entry, quality review, finalization and EVHUMAN case downloads and processing. Responsible for PV literature surveillance activities. Screening and review of literature articles/ abstract/citations. Medical literature monitoring (MLM) EVWEB case processing knowledge. Responsible for determining ICSR reportability, experienced in various formats of ICSR reporting that is submitted to Regulatory authorities, like xml (E2B R2/R3) format for EVWEB upload, E2B gateway reporting and transmission, Portal submissions, courier, and manual email submissions of CIOMS, MEDWATCH. Review and perform coding for all required medical (MedDRA)/drugs (WHO DD) terms according to given coding dictionaries and applicable coding guidelines. Following up with sites regarding outstanding queries and clarification on follow up cases. Provides training for new hires and other PV Specialist in the performance of tasks. Data retrieval from safety database.  Participated in regulatory audits and inspections in cooperation with Quality Assurance (QA) team as needed. Knowledge on experience in FDA/EU/ICH guidelines and regulations relating to safety and PV reporting. Provides project support related to safety database issues and data outputs. Maintain a high level of expertise regarding Safety Systems through participation in internal meetings and professional seminars and workshops. Ability to work independently and in a team environment. Able to make effective decisions. Show less

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  Bioclinica

  Nov 2015 - Aug 2016

  Drug safety scientist/business sme/ sr. submission specialist/ csv lead

   Driving the validation end to end process in close collaboration with stakeholders, IT team and Quality Assurance (QA) team.  Responsible for analyzing, understanding, gathering Business requirements to plan an effective testing methodology. Preparing testcase design, review, execution, and documentation. Execute all levels of testing (System test/Dry Runs/Regression and Deployment). Responsible for preparing and review test cases results, and anchor defects prevention activities.  Responsible for developing test strategy, track, monitor project plans and preparing solution delivery of projects along with reviewing of test plans, test cases and test scripts. Authoring Validation deliverable like user requirements specification (URS/URD), functional requirements specification (FRS), Validation Plan, SOPs, Performance Qualification (PQ), Operational Qualification (OQ), Traceability matrix, UAT summary report (UATSR), and user guidance documents.  Ensured components are properly tested to meet technical requirements Provides support activities for process and tool improvement. Initiation of change requests (CR/RFC) through change control queue for new or customized configuration requests and ad-hoc requests. Act as a system administrator (activation, modification, or deactivation of new user access requests, assigning roles), configuration verification and configuration specification.  Working experience on multiple standard database ARISg, ARGUS, SCEPTRE and ABCUBE (SAFETYEASY). Good understanding knowledge of Pharma Regulatory requirements including GxP, EU Annex 11, CFR Part 11 and GAMP5 guidelines. Being a point of contact for validation during audit and inspections. Successfully completed ARISg database configuration implementation, upgradation, and validation for many stakeholders across the world. Show less

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  Teva pharmaceuticals

  Sept 2021 - now

  System specialist

  Pharmacovigilance safety system support during development, implementation and upgradation.