Ronak R.

Manager Business Development at BioAro Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
Calgary, Alberta, Canada, CA

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Credentials

  • TWC3001 - Technical writing and scientific communication
    Academy of Applied Pharmaceutical Sciences
    Sep, 2023
    - Nov, 2024
  • CR028 Global clinical research and pharmacovigilance
    Academy of Applied Pharmaceutical Sciences
    Jun, 2023
    - Nov, 2024
  • CR021 - Clinical Data Acquisition and Data Management
    Academy of Applied Pharmaceutical Sciences
    May, 2023
    - Nov, 2024
  • Drug Lifecycle Safety Management and Pharmacovigilance Compliance
    Academy of Applied Pharmaceutical Sciences
    May, 2023
    - Nov, 2024
  • Clinical Project Management and Project Chart Development
    Academy of Applied Pharmaceutical Sciences
    Apr, 2023
    - Nov, 2024
  • Organization of Clinical Trials and Clinical Monitoring Plan Development
    Academy of Applied Pharmaceutical Sciences
    Apr, 2023
    - Nov, 2024
  • Clinical Research Regulations and Good Clinical Practices (GCP) Certificate
    Academy of Applied Pharmaceutical Sciences
    Mar, 2023
    - Nov, 2024
  • Legislations, Ethics and Good Pharmacovigilance Practices (GVP) Certificate
    Academy of Applied Pharmaceutical Sciences
    Mar, 2023
    - Nov, 2024
  • Clinical Pharmacology and Clinical Safety Assessments Certificate
    Academy of Applied Pharmaceutical Sciences
    Feb, 2023
    - Nov, 2024
  • The Canadian Pharmaceutical Industry Big Picture
    Academy of Applied Pharmaceutical Sciences
    Feb, 2023
    - Nov, 2024

Experience

    • Canada
    • Biotechnology Research
    • 1 - 100 Employee
    • Manager Business Development
      • Oct 2023 - Present

    • Sales and Marketing Executive
      • Jul 2023 - Oct 2023

    • Canada
    • Food & Beverages
    • 500 - 600 Employee
    • Fulfillment Associate
      • Feb 2023 - Apr 2023

    • United States
    • Software Development
    • 700 & Above Employee
    • Warehouse Associate
      • Oct 2022 - Dec 2022

    • India
    • Information Technology & Services
    • 200 - 300 Employee
    • Senior Process Associate
      • Nov 2019 - Mar 2022

      ● Maintained a high degree of confidentiality and sensitivity towards personal information, ensuring compliance with HIPAA regulations and preserving patient privacy. ● Reviewed clinical chart documentation with meticulous attention to detail, validating the accuracy of services coded by the physician team for billing purposes, resulting in a 98% billing accuracy rate. ● Conducted thorough research, analysis, and evaluation of medical records to be submitted, ensuring adherence to regulatory requirements and achieving a 95% accuracy rate in record review. ● Utilized various databases for financial care activities including eligibility verifications, prior authorizations, and Remittance advice and was responsible for providing research and Root Cause Analysis for Claims remediation. Show less

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior pharmacovigilance Associate
      • May 2018 - Aug 2019

      ● Conducted initial triage of received source documentation, accurately identifying safety concerns and categorizing them as either Product Quality Complaints (PQC) or Adverse Event (AE) Reports, resulting in a 99.9% accuracy rate. ● Analysed and processed Individual Case Safety Reports (ICSRs) sourced from various channels, including Literature reports, Health authority and Spontaneous reports, achieving a monthly average processing volume of 500 reports with a 98% accuracy rate. ● Demonstrated strong planning and organizational skills by efficiently prioritizing cases based on their seriousness, ensuring prompt attention to Serious Adverse Events (SAEs) and reducing response time by 20%. ● Assisted to the submission of cases to pertinent regulatory agencies, such as the US-FDA, EMEA, MHRA, ANVISA, HEALTH CANADA, and DMA, in strict accordance with their regulations, maintaining a 100% compliance rate, and meeting all deadlines for submission. Show less

    • India
    • Research Services
    • 700 & Above Employee
    • Research associate
      • Mar 2017 - Apr 2018

      ● Assessed the reportability of Individual Case Safety Reports (ICSRs) using the project-specific Safety Reporting Assessment sheet, resulting in a 98.5% accuracy rate in determining reportability. ● Tracked and reconciled processed reports, ensuring timely follow-up for reported adverse events and achieving a 95% resolution rate within established timelines. ● Assessed pharmacovigilance data for reportability to relevant authorities, including Regulatory Authorities, Ethics Committees, IRB, Investigators, and oversight bodies, ensuring compliance with regulatory guidelines and achieving a 100% submission rate. ● Successfully tracked and monitored reportable cases, maintaining a comprehensive database and generating accurate reports for regulatory submissions, with an average of 200 reportable literature and clinical trial cases tracked per month. ● Played a key role in training new associates, providing comprehensive guidance and support throughout the end-to-end workflow, resulting in a 90% successful onboarding rate and reducing training time by 40%. Show less

    • India
    • Research Services
    • 300 - 400 Employee
    • Research Officer
      • Feb 2017 - Mar 2017

      ● Conducted rigorous data verification by performing source data/document verification (SDV) in BA/BE studies, ensuring 100% consistency between the data entered in Case Report Forms (CRFs) and clinical notes. ● Assessed and evaluated the suitability of facilities for use as clinical trial sites, resulting in the successful identification of suitable sites. ● Conducted audits of Case Report forms to verify their accuracy and appropriateness for reporting purposes, achieving a 99% accuracy rate in data validation and enhancing overall data integrity. Show less

    • United States
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Back Office Executive
      • Jan 2016 - Jul 2016

      Medical Billing and Claims reviewer Medical Billing and Claims reviewer

    • United Kingdom
    • 1 - 100 Employee
    • Product Specialist
      • Mar 2013 - Oct 2015

      Branch Manager/Sales Branch Manager/Sales

Education

  • Academy of Applied Pharmaceutical Sciences
    Post graduate diploma, Clinical research
    2023 - 2023
  • Rajasthan University of Health Sciences, Jaipur
    Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
    2008 - 2012
  • Rajasthan University of Health Sciences, Jaipur
    Master's degree, Medicinal and Pharmaceutical Chemistry
    2014 - 2016
  • Academy of Applied Pharmaceutical Sciences
    Postgraduate Diploma, Clinical Research
    2023 - 2023

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