Experience

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  Kachhua education services llp

  May 2016 - Sept 2016

  Project coordinator

  During my initial months after education, I was open to learning other skills till I got a job in the medical category. I worked here as Project Coordination for 5 months and learned many skills.• providing content related guidance to the team in science education of k10.• Managed assigned area ensuring production, Quality control, cost control and continuous improvement with market ready product.• Conducted meetings and one-on-one conversation to effectively communicate company policy, objective, and performance feedback.• Supervised and coordinated team of 15 people. Show less

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  Lambda therapeutic research limited., ahmedabad

  Oct 2016 - Jul 2018

  Clinical research associate

  Pharmacovigilance ·• Review, assess, triage and process adverse event reports according to applicable regulations, guidelines, SOPs and project requirements within the specified timelines by meeting quality standards.• Ensure a duplicate check is conducted against the Global Safety Database in accordance with SOPs for all ICSRs (Individual Case Safety reports) to determine whether there is an existing case file.• Creating an electronic case report file for a new case.• Assessment of case reports for seriousness, case validation, causality and expectedness.• Prioritizing the adverse event report processing based on the ICH dates.• Perform literature review for creating a valid case• Perform safety data entry in the database, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality control and ensure case reporting.• Coding of medical history, drugs and reported adverse event terms in safety database using medical dictionaries like MedDRA.• Filing PQCs (product quality complaints) associated with adverse events.• Performing quality review and checking cases for discrepancies for any errors related to labelling and narrative writing.• Setting up follow-up letter to the reporter for further case follow-up as per the applicable guidelines and reporting the case to the respective regulatory agencies.• Attend project team meetings and client calls related to the project and provide feedback to operation manager on any challenges/issues or successes.• Respond medical inquiries from consumers and healthcare professionals • Assist and provide data to PSUR team to generate Periodic Safety Update Reports and signal detection Show less

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  Cannapiece corp

  Sept 2021 - now

  Process systems specialist

  • Timely review of batch records, including manufacturing, packaging, and labeling to ensure completeness, accuracy, and compliance as per company SOPs and government regulations• Configure controlled label templates• Perform line clearance for GPP activities; also perform in-process checks• Respond and resolve clients’ complaints, nonconformances, deviations and CAPA investigations• Follow up on all issues to ensure if it is addressed and completed prior to submitting batch records to Quality Assurance Person (QAP) for release• Perform analysis of production data to identify trends and recommend changes to quality procedures when necessary• Participate in the reviewing of trial designs to contribute to quality requirements• Collaborate with other departments, such as production and maintenance to ensure compliance with Health Canada regulations• Prepare and organize the documentation required for clients’, company, and health Canada audits • Train production staff for cGMP and GDP training and document the training log Show less