MI Operations Specialist 1

Job Overview

The Operations Specialist - Medical Information- 100% remote will review assess and process safety data from multiple sources ensuring accurate case handling and timely distribution of reports to internal and external stakeholders. All activities must follow global regulations SOPs and projectspecific guidelines with support from senior team members.

Key Responsibilities

• Process and triage safety data according to regulations SOPs and project requirements.
• Collect track and assess incoming adverse events determining initial vs. followup status.
• Perform database entry MedDRA coding narrative writing and literature surveillance.
• Maintain quality and productivity standards while ensuring full compliance with all procedures.
• Create update and track cases according to project plans.
• Identify and escalate quality issues to senior team members.
• Collaborate with crossfunctional teams (project management clinical data management) and healthcare professionals (investigators medical monitors site staff).
• Communicate with clients regarding daytoday case processing when required.
• Support onboarding and mentoring of new team members when assigned.
• Participate in team meetings audits and inspections.
• Contribute to departmental initiatives and maintain 100% compliance with people processes.
• Depending on project needs perform medical review of nonserious AEs/ADRs including coding checks medical history review concomitant medications expectedness causality assessment and documentation.

Required Qualifications

• Bachelors degree in a scientific healthcare or lifescience field.
• Up to 3 years of experience in pharmacovigilance or equivalent training.
• Advanced English required.
• Strong knowledge of medical terminology and global safety regulations.
• Experience with safety databases and client/internal applications.
• Excellent attention to detail accuracy and quality standards.
• Proficiency in Microsoft Office and webbased tools.
• Strong organizational and timemanagement skills.
• Ability to work independently follow guidelines and manage multiple priorities.
• Strong teamwork skills and ability to build effective working relationships.
• Ability to work shifts and travel occasionally if required.

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. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.