Iqvia

Overview

As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities. Review, assess, and process safety data and information received from various sources.

About Iqvia

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Requirements & Eligibility

• Bachelor's degree in life sciences
• Advanced level of English
• 2-3 years of experience in pharmacovigilance activities (mandatory) Specifically in regulatory reporting, will be highly valued
• Previous experience working with Argus is required
• Good knowledge of medical terminology and applicable safety databases
• Strong organizational skills, attention to detail, and ability to work independently and as part of a team

Key Responsibilities

• Process safety data according to applicable regulations, guidelines, SOPs, and project requirements
• Ensure compliance with quality, productivity, and delivery standards per project requirements
• Track cases as applicable to the project plan
• Identify and report quality problems to senior team members
• Liaise with different functional team members and health care professionals to address project-related issues
• Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes