Phani Kumar C.

Experience

• 

  SMS Pharmaceuticals Ltd

  Oct 2010 - Nov 2010

  Industrial Trainee
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  Millennium Technosoft Pvt Ltd

  Mar 2013 - Sept 2013

  Data Processor
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  UnitedHealth Group

  Oct 2013 - Nov 2013

  Trainee Medical Coder
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  Synowledge LLC

  Nov 2013 - Dec 2015

  Drug Safety Associate

  As Quality Check Reviewer/ Triager• Review data entered in ARISg 7.0 safety database for completeness and accuracy.• Provide quality feedback to team resources.• Track and maintain quality metrics.• Central Triage of cases received and check for seriousness, causality and expectedness.• Code the primary event and provide Triage assessment.• Raise Queries for the unlisted events and Triage notes for Medical review.As Case Processor: • Responsible for data entry of Individual case safety reports (ICSR) into the safety database.• Review and evaluate AE case information to determine required action based on and following internal policies and procedures.• Full data entry including medical coding and safety narrative. As Medical Coder:• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).As Narrative Writer:• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.Other Responsibilities: • Generating weekly lists of all cases and analysis replies handled by the team.• Training and delegate work as appropriate to Drug Safety Associates/ Query Management team.• Following up with sites regarding outstanding queries.• Follow up on reconciliation of discrepancies.• Follow departmental AE workflow procedures. Show less

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  IQVIA

  Dec 2015 - May 2016

  Assoc Operations Specialist, Data Sciences, Safety & Regulatory

  • Receive, triage, review and process data from various sources on time, within budget and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of primary review. • Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. • Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. • Assist operations team with tasks, provide for back-up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes. • Contribute under guidance of senior staff to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate. • Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. • Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. • May liaise with client in relation to details on day to day process of cases. Show less

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  Cognizant

  Jun 2016 - Sept 2020

  • Data Analyst - Aggregate Reporting

    Sept 2018 - Sept 2020

  • Junior Data Analyst

    Jun 2016 - Sept 2018
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  Covance

  Oct 2020 - Nov 2021

  Medical Writer
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  Syneos Health

  Nov 2021 - now

  Senior Medical Writer
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  Bausch Health Companies Inc.

  Apr 2023 - now

  Aggregate Reports

  Client role (SME/Assoc.Dir/Vendor Management) for Sitero