Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

VIGNESH KUMAR

Pudukkottai

Summary

Dr. Vignesh Kumar. K is an Operations
Specialist 1 in the safety department of the Lifecycle Safety at IQVIA. At present I have 4 years plus experiences for the date of 05-Sep-2019. I am known for high productivity and efficient task completion. Possess specialized skills in regulatory compliance, risk assessment, and policy development. Excel in critical thinking, problem-solving, and communication, ensuring seamless navigation through complex regulatory environments.

Overview

2
2
years of professional experience

Work History

Operations Specialist

IQVIA
Bengaluru
03.2022 - Current
  • To perform assessment of reportability for cases to various Health Authorities based on
    information available in each unsolicited /solicited / literature / health authority case and performing regulatory submissions to various Health Authorities within timelines.
    ▪ To monitor regulatory compliance alongside identifying, investigating and raising deviations such as SUDRs and NCOs along with providing new corrective and preventive actions
    ▪ Ensure to meet quality and productivity standards per project requirements.
    ▪ Identify quality problems, if any, and bring them to the attention of a senior team member.
    ▪ Attend project team meetings and provide feedback to operations manager on any
    challenges / issues or successes.
    ▪ To observe trends in error findings of all team members that affect regulatory compliance and improve quality by performing reconciliation by analyzing regulatory compliance reports with
    individual regulatory overview and workflow reports
    ▪ To observe trends in error findings of all team members that affect regulatory compliance and improve quality by preparing inline quality report and monthly error trend report
    ▪ To perform weekly reconciliation of submissions to avoid any under-reporting to any authority from the team
    ▪ To perform triage and assign cases to team members
    ▪ To prepare a daily action plan for the team ensuring timely completion of cases and
    activities.
    ▪ To work on regulatory retrospective analysis as needed
    ▪ To prepare and timely update project specific and workflow specific reference documents for current team members.
    ▪ To work on workflow management
    ▪ To provide RCA for instances missed KPIs
    ▪ Process Safety data according to applicable regulations, guidelines, Standard Operating
    procedures (SOPs) and project requirement
    ▪ Data entry of the adverse events including patients’ demographical data, suspect and concomitants, selection and detailing of adverse events, action taken, de- challenge and re-challenge, history and diagnostic details (Solicited, spontaneous and literature sources)
    ▪ Writing descriptive narratives, reviewing, analyzing correct and appropriate safety information and generating queries pertinent to the case.
    ▪ To function as a trainer responsible for training newly onboarded team member
    ▪ To Prioritize and complete the assigned trainings on time.
    ▪ To ensure compliance to all project related processes and activities.

Education

Doctor of Pharmacy - Pharmacy

JSS College of Pharmacy
Ooty, TN
06-2019

Skills

  • Regulatory submissions
  • MedDRA coding
  • Leadership Confidence
  • Strong Time management abilities
  • Communication skills
  • Collaboration and teamwork
  • Flexibility in handling various tasks

Accomplishments

  • IQVIA Impact Program from which I had received Bronze, Spotlight and
    Ovation awards.

Timeline

Operations Specialist

IQVIA
03.2022 - Current

Doctor of Pharmacy - Pharmacy

JSS College of Pharmacy

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