RaviKumar R
Bengaluru
Summary
Dynamic Operation Specialist with a proven track record at IQVIA, enhancing operational efficiency and ensuring regulatory compliance in safety data management in Post marketing and Clinical trial project. I excel in transforming challenges into actionable solutions, significantly improving project outcomes without compromising quality.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Operation Specialist
IQVIA
Bengaluru
01.2018 - Current
- Reviewed and assessed safety data from multiple sources from clinical trial and post-marketing projects.
- Monitored and ensured safety data reporting compliance with regulatory standards.
- Handled comprehensive management of individual case safety reports, focusing on data entry and quality assurance.
- Complete ICSR process Management (all case types)
- SME trainer and mentor
- Providing and improving
- Managing day to day Operations - Case allocation, monitoring workflow, tracking cases till completion as per KPIs
- Lead and work with the teams to optimize processes and leverage pharmacovigilance‐related technology to build a more efficient organization
- Scheduling and attending internal and external meetings (Sponsor) to confirm and clarify the doubts/updates/new process improvement ideas on process.
- Case processing/QC/Bookin, Triage, Mailbox management, Sponsor notification of SAE’s of various projects
Education
B.Tech - Biotechnology
Adhiyamaan College of Engineering
Tamilnadu04-2015
Skills
- Operational efficiency
- Scheduling coordination
- Workforce planning
- SAS 94 Base Programming
- Sound knowledge of CDISC, SDTM, and ADaM
Certification
- Certified in SAS 9.4 Base Programming - Performance-Based
Languages
Telugu
First Language
Tamil
Advanced (C1)
C1
Kannada
Beginner (A1)
A1
Accomplishments
- Ovation, Spotlight and bronze award for best performance in IQVIA from the year of 2021 to 2024
Timeline
Operation Specialist
IQVIA
01.2018 - Current
B.Tech - Biotechnology
Adhiyamaan College of Engineering
Similar Profiles
Megan MunroeMegan Munroe
Associate Scientist at IQVIAAssociate Scientist at IQVIA
Asmat ShaikhAsmat Shaikh
Associate Director, Safety Project Leadership at IQVIAAssociate Director, Safety Project Leadership at IQVIA
Lokesh ALokesh A
Salesforce Engineer-2 at IQVIASalesforce Engineer-2 at IQVIA