Chandan Reddy Allam

Experience

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  Bioclinica

  Sept 2015 - Sept 2016

  ● Assist in representation of Global Safety and PV group at project team and client meetings.● Review data entered in the safety database for completeness and accuracy.● Provide quality feedback to team resources.● Track and maintain quality metrics.● Review and evaluate AE case information to determine required action based on the internal policies and procedures.● Process all incoming cases to meet timelines.● Following up with sites regarding outstanding queries.● Follow up on reconciliation of discrepancies.● Follow departmental AE workflow procedures.● Closure and deletion of cases.● Mentor and guide the activities of Drug safety associate.● Perform any other drug safety related activities as assigned.● Responsible for data entry of individual case safety reports or clinical reports into safety database.● Responsible for coding all medical history, events, drugs/procedures/indications and lab tests according to the appropriate dictionary [For e.g. MeDRA, Company Product dictionary, WHO DD).● Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in various fields.● Responsible for case triage, intake, duplicate check and registration of safety reports. ● Report any inconsistencies in processing to senior drug safety associate. Show less • Receive, triage, review and process SAE and /Adverse event reports from various sources on time (CT, spontaneous and literature) and quality standards• Writing narratives: Create complete, accurate and succinct narratives adhering to established processes• Authoring PBRERs and Canadian Annual Summary reports• Identifying SAEs and AEs from literature sources and processing them appropriately• Writing narratives: Create complete, accurate and succinct narratives adhering to established processes Show less

  • Drug Safety Associate

    Mar 2014 - Sept 2016

  • Senior Drug Safety Associate

    Sept 2015 - Aug 2016
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  IQVIA

  Nov 2016 - Sept 2020

  Operations Specialist I

  ● Responsible for allocation of literature articles and tracking compliance according to global pharmacovigilance (PV) regulations and guidelines.● To perform pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming adverse event (AE)/endpoint information; determining initial/update status of incoming events; database entry and reconciliation; writing narratives, reviewing relevant literature as per internal/project timelines.● Ensure to meet quality standards as per project requirements.● Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. ● Ensure all required training is executed in a timely fashion and documented.● Identify quality problems, if any, and bring them to the attention of operations manager.● To demonstrate problem solving capabilities.● To mentor new team members, if assigned by the manager.● Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Show less

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  Cognizant

  Mar 2021 - Oct 2023

  Team Lead

  • Developed and implemented comprehensive quality assurance processes for pharmacovigilance activities, ensuring compliance with project guidelines.• Took part in audits, inspections, and assessments to identify and address quality gaps.• Analyzed safety data to identify trends, root causes of issues, and areas for improvement in pharmacovigilance processes.• Provided constructive feedback and coaching to team members to enhance performance and adherence to quality standards.• Collaborated with senior management to develop strategic goals and initiatives for quality improvement in pharmacovigilance.• Maintained and documented all quality assurance processes as per company policies. Show less