(Senior) Safety Reporting Coordinator (Office-Based) - IQVIA Biotech (R1082505) in Morrisville, NC at IQVIA™

Date Posted: 8/3/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    8/3/2019
  • Job ID:
    R1082505

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

IQVIA Biotech is seeking a (Senior) Safety Reporting Coordinator (Office-Based in Morrisville, North Carolina):

BASIC FUNCTION:

Assists with the delivery of global safety reporting services including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) and Medical Devices (MD) according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech Standard Operating Procedures (SOPs) and/or project specific procedures.

Primary responsibilities include monitoring and tracking expedited safety reports and periodic report submissions.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Monitors the safety regulatory reporting email box.
  • Monitors the safety database and or project specific tracking tool to identify when cases have been finalized for reporting.
  • Tracks anticipated regulatory reports against case status in safety database or project specific tracking tool and follows up with assigned safety associate on case status as required.
  • Assists with the QC of set-up of reporting destinations in safety database, as applicable.
  • Assists with scheduling and submitting reports in the safety database, as applicable.
  • Enters electronic reporting acknowledgement dates/documentation in the safety database or project specific tracking tools/files.
  • Assists with developing and maintaining safety submission tracking reports, communicating regularly with Safety Management Lead and team on status of activities.
  • Assists with obtaining and documenting regulatory intelligence.
  • Generates cover letters and other documents for expedited reporting packages and periodic reports.
  • Maintains safety reporting calendar for aggregate reports (i.e. report due dates, data cut-off dates).
  • May assist management and/or Safety Reporting Specialist in writing processes and developing documents related to intake/triage functions, including study-specific processes.
  • Provides general administrative support to projects as requested (e.g., taking minutes, copying, filing, faxing, scheduling).
  • May mentor and/or train new Safety Management staff.
  • Performs other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Safety Reporting activities.
  • Excellent written and verbal communication skills.
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative with oversight.
  • Knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
  • Experience working in electronic data management systems or safety databases (Argus experience preferred).
  • Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very limited physical effort required to perform normal job duties.

MINIMUM RECRUITMENT STANDARDS:

  • Prior experience in clinical trial safety preferred.
  • Computer literacy and experience working with Microsoft Office (Word, Excel) required.
  • Good written and verbal communication skills required.
  • Good interpersonal and organization skills required.
  • Ability to work independently and prioritize effectively. 

CLASSIFICATION:

This position is classified as non-exempt; employees are eligible for overtime compensation subject to prior approval.
 

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1082505