Sr/Safety Operations Specialist

Job Overview

Apply knowledge and expertise, including complex decision-making activities, to review, assess, and process safety data and information across service lines. Recognized as a specialist in one or more areas. Provide oversight on small to medium service operational projects and act as a mentor to junior staff members.

Essential Functions

• Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.

• Perform pharmacovigilance activities, including collecting and tracking incoming adverse events (AEs) and endpoint information.

• Determine initial/update status of incoming events, database entry, coding AEs and products, writing narratives, and performing literature-related activities.

• Conduct quality reviews, assist with reconciliation, case closure activities, and coordinate translations as per project timelines.

• Assess safety data for reportability to relevant authorities and track/report cases to regulatory bodies, ethics committees, and other oversight groups.

• Contribute to or lead deliverables in safety publishing, risk management, safety surveillance, and medical information.

• Ensure compliance with all project-related processes and activities, meeting quality, productivity, and delivery standards.

• Build a positive, collaborative team environment, providing training and mentoring for less experienced team members and operations staff.

Qualifications

• Bachelor’s degree in a scientific or healthcare discipline, or allied life sciences.

• At least  1 year in pharmacovigilance.

• Experience with case processing in Argus for clinical trial studies preferred.

• Advanced level of English

• Excellent knowledge of medical terminology and applicable safety databases.

• Strong organizational skills, attention to detail, and the ability to manage multiple tasks and deadlines.

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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