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Job Overview

The Pharmacovigilance and Case Intake Specialist/OperationsSpecialist 1 reviews, assesses, and processes safety data. This role involves distributing reports/data to internal and external parties, following regulations, SOPs, and guidelines with support from senior team members.

Essential Functions

• Complete assigned training on time.
• Process safety data per regulations, guidelines, SOPs, and project requirements.
• Perform pharmacovigilance activities, including:
• Collecting and tracking Adverse Events (AEs).
• Determining status of incoming events.
• Database entry and coding AEs/products.
• Writing narratives and conducting literature-related activities.
• Ensure quality and productivity standards are met.
• Comply with all project-related processes and activities.
• Read and acknowledge necessary SOPs and ensure timely training.
• Create, maintain, and track cases.
• Identify and report quality issues.
• Demonstrate problem-solving skills.
• Liaise with team members and healthcare professionals to address project issues.
• May liaise with clients on case processing activities.
• Mentor new team members if assigned.
• Attend project meetings and provide feedback.
• Perform other duties as assigned.
• Lead/support department initiatives.
• Ensure compliance with all people practices and processes.
• Perform medical review of non-serious AEs and ADRs as required.

Qualifications

• Bachelor's degree in life sciences
• Up to 1 year in pharmacovigilance and/or intake case processing experience, desirable.
• Advanced level of English
• Advanced level of German
• Excellent attention to detail and accuracy.
• Ability to delegate and adapt to changing demands.
• Willingness to learn new skills across safety service lines.
• Ability to establish effective working relationships with coworkers, managers, and clients.

100% remote role

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 https://jobs.iqvia.com