Ronak R.
Manager Business Development at BioAro Inc.- Claim this Profile
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Bio
Credentials
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TWC3001 - Technical writing and scientific communication
Academy of Applied Pharmaceutical SciencesSep, 2023- Nov, 2024 -
CR028 Global clinical research and pharmacovigilance
Academy of Applied Pharmaceutical SciencesJun, 2023- Nov, 2024 -
CR021 - Clinical Data Acquisition and Data Management
Academy of Applied Pharmaceutical SciencesMay, 2023- Nov, 2024 -
Drug Lifecycle Safety Management and Pharmacovigilance Compliance
Academy of Applied Pharmaceutical SciencesMay, 2023- Nov, 2024 -
Clinical Project Management and Project Chart Development
Academy of Applied Pharmaceutical SciencesApr, 2023- Nov, 2024 -
Organization of Clinical Trials and Clinical Monitoring Plan Development
Academy of Applied Pharmaceutical SciencesApr, 2023- Nov, 2024 -
Clinical Research Regulations and Good Clinical Practices (GCP) Certificate
Academy of Applied Pharmaceutical SciencesMar, 2023- Nov, 2024 -
Legislations, Ethics and Good Pharmacovigilance Practices (GVP) Certificate
Academy of Applied Pharmaceutical SciencesMar, 2023- Nov, 2024 -
Clinical Pharmacology and Clinical Safety Assessments Certificate
Academy of Applied Pharmaceutical SciencesFeb, 2023- Nov, 2024 -
The Canadian Pharmaceutical Industry Big Picture
Academy of Applied Pharmaceutical SciencesFeb, 2023- Nov, 2024
Experience
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BioAro Inc.
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Canada
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Biotechnology Research
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1 - 100 Employee
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Manager Business Development
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Oct 2023 - Present
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Sales and Marketing Executive
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Jul 2023 - Oct 2023
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Goodfood Market (TSX:FOOD)
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Canada
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Food & Beverages
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500 - 600 Employee
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Fulfillment Associate
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Feb 2023 - Apr 2023
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Amazon
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United States
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Software Development
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700 & Above Employee
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Warehouse Associate
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Oct 2022 - Dec 2022
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Integrity Healthcare Solutions Pvt Ltd
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India
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Information Technology & Services
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200 - 300 Employee
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Senior Process Associate
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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
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APCER Life Sciences
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior pharmacovigilance Associate
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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
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Lambda Therapeutic Research
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India
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Research Services
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700 & Above Employee
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Research associate
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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
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Accutest Research Laboratories (I) Pvt. Ltd.
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India
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Research Services
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300 - 400 Employee
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Research Officer
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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
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SpeedBirdServices - Medical Billing Company
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United States
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Hospitals and Health Care
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1 - 100 Employee
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Back Office Executive
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Jan 2016 - Jul 2016
Medical Billing and Claims reviewer Medical Billing and Claims reviewer
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CHEMOPHARM
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United Kingdom
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1 - 100 Employee
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Product Specialist
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Mar 2013 - Oct 2015
Branch Manager/Sales Branch Manager/Sales
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Education
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Academy of Applied Pharmaceutical Sciences
Post graduate diploma, Clinical research -
Rajasthan University of Health Sciences, Jaipur
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences -
Rajasthan University of Health Sciences, Jaipur
Master's degree, Medicinal and Pharmaceutical Chemistry -
Academy of Applied Pharmaceutical Sciences
Postgraduate Diploma, Clinical Research