Vanam Chanukya

Experience

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  IQVIA

  Jul 2018 - Aug 2019

  Drug Safety Associate

  Maintaining a good working knowledge of the AE safety profile of assigned drugs and labeling documents.Maintaining an excellent knowledge of case processing conventions and guidelines, client’s procedures, and international drug safety regulationsProcess ICSR according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.Perform data entry for tracking, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality review, assisting withreconciliation, driving case closure, requesting translations, and ensuring ICSR are processed within assigned timelines.Performing single case creation/initiation in the safety database. Show less

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  Santhiram College of Pharmacy, Nandyal

  Aug 2019 - Sept 2021

  Assistant Professor

  Sound knowledge of pharmacotherapy and clinical pharmacy subjects.• Provide teaching and training for pharmacy clerkship students and residents.• Work two days a week as a bedside trainer at Santhiram general hospital and medicalcollege providing patient care and student supervision.• Developing publications for journals, conferences, and workshops, and presentingpapers at conferences and workshops.• Participated in faculty development programs and student induction programs Show less

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  Qinecsa Solutions

  Sept 2021 - May 2023

  Drug Safety Associate 1

  ICSR Case processing and quality review for Biologics, Anticancer products and for other pharma drugs in Argus safety database 8.2.1.Ensure accurate transfer of information from initial and follow-up source documents or E2B inputs for adverse event reports to appropriate fields within Argus; code adverse events using MedDRA, create narrative of the adverse events, and manage case reports within the Argus workflow to meet local and global regulatory timelines.Worked on serious, non-serious, device, product quality complaints, invalid and at- risk cases.As a case processor identify and select the cases from a workflow, determining appropriate prioritization criteria and submission dates.Compliance with process requirements review the coding of suspect drugs using the Company Drug Dictionary and WHO Drug Dictionary.Review the coding of Concomitant Drugs, Treatment Drugs and Past Drugs using the WHO Drug Dictionary.Review the seriousness criteria of all the adverse events and upgrade the events listed in "Always Serious List", following the established procedure.Labeling the events according to the Company Core Data Sheet.Generate CIOMS and E2B forms and check for the tab and narrative case consistency.Check the ICSR validations before routing the case for generation of reports.As a Peer reviewer performed peer review for the case processors for spontaneous, lateritious-spontaneous, non- interventional study cases.Track the completion of all assigned trainings and perform additional duties assigned for the team.Served as a buddy reviewer for the associates with low quality and helped to improve the quality. Show less

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  ArisGlobal

  May 2023 - now

  Technical suppprt engineer

  Collaborated closely with the Product Manager to gather and understand software requirements, utilizing JIRA tickets to track and manage the process.Authored comprehensive operational qualifications for software requirements, ensuring alignment with industry standards and client needs.Conducted thorough testing on newly developed software requirements, collaborating with developers to validate functionality and identify potential issues.Executed smoke tests on use cases to ensure the stability and basic functionality of the software, utilizing Application Lifecycle Management (ALM) tools.Coordinated with global customers to provide expert technical support, effectively resolving issues related to the LifeSphere Multivigilance application.Demonstrated exceptional problem-solving skills, effectively diagnosing and troubleshooting software-related problems to deliver timely solutions.Maintained accurate records of customer interactions, issues, and resolutions, contributing to the continuous improvement of support processes.Collaborated with cross-functional teams to provide valuable insights for product enhancements based on customer feedback and recurring issues.. Work with various product & application installation and configuration• Assist or work to deliver post-sales support and solutions to the Arisglobal customer base while serving as an advocate for customer needs. This involves inquiries via phone and electronic means.• Address the customers on technical questions regarding the use of and troubleshooting of our products.• Serve as a point of contact for customers/regional stakeholders of Arisglobal/regional deployment leads.• Responsible for facilitating professional relationships with customer, support and providing advice / assistance to internal Arisglobal employees on diverse customer/deployment situations and escalated issues.• Work on customer specific or product specific internal function specific end to end product deployments. Show less