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Job Overview

Review, assess, and process safety data and information across service lines, received from various sources. Distribute reports/data to both internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members. This is a trilingual role requiring fluency in English, Spanish, and French.

Main Responsibilities

• 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, determining initial/update status of incoming events, database entry, coding AEs and products, writing narratives, and literature-related activities.
• Ensure compliance with quality, productivity, and delivery standards per project requirements.
• Liaise with different functional team members and healthcare professionals to address project-related issues.
• To Prioritize and complete the assigned trainings on time.
• Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
• Liaise with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
• May liaise with client in relation to details on day-to-day case processing activities.
• To mentor new teams members, if assigned by the Manager.
• Perform other duties as assigned.
• Lead/ Support department Initiatives
• In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.

Qualifications

• Bachelor’s degree in Life sciences or a related field (mandatory)
• Fluency in English and French (mandatory)
• 1 year of pharmacovigilance experience will be highly valued
•  Good working knowledge of Microsoft Office and web-based applications. Intermediate

100% home-based 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