Experience

IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Associate Safety Project Manager

  • Mar 2021 - Present

• Associate Manager

  • Nov 2019 - Feb 2021



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Operations Specialist

  • Jan 2017 - Nov 2018

• Operations Specialist

  • Apr 2015 - Dec 2016

  • Quality review of clinical trial and post box initial and updated safety data, reviewing safety data for inconsistencies, contacting sites with queries as needed, ensuring safety data is corrected by site staff, ensuring translation of safety data; review of safety data entered into a Serious Adverse Event (SAE) database, narratives, coding of terms, queries as appropriate.• Ensuring reports are sent to customers or marketing authorization holders within agreed timelines.• Liaising with medical reviewers, CSS and global leads, and customers.• Subject matter expert for projects, mentoring new team members and provide training regarding project conventions.• Back up lead activities like case allocation, managing workflow, leading team meetings, filing deviations, attending client calls, performing random QC, updating metrics database, reviewing status reports and safety management plans (SMPs).• Performed User acceptance testing for Argus Safety database.

• Associate Operations Specialist

  • Nov 2012 - Mar 2015

  Key Responsibilities:• Process clinical trial as well as post marketing safety data, reviewing safety data for inconsistencies, contacting sites with queries as needed, and entering applicable safety data into a serious adverse event database.• Coding relevant medical terminology, writing comprehensive narratives, assisting with reconciliation and case closure. • Performing Quality Review and ensuring reports are sent to customers or marketing authorization holders within agreed timelines.• 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.• Experience in medical writing; writing and QC of patient narratives for CSR and DSMB reports. • Experience in different therapeutic areas such as cardiovascular, rheumatology, immunology and oncology. • Proficient in working with ARISg database, Argus database, Inform and Oracle AERs.