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Job Description Summary

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. Proficiency in French is required.

Essential Functions

• Prioritize and complete assigned trainings on time.

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

• Perform pharmacovigilance activities per project requirements, including but not limited to:

  • Collecting and tracking incoming Adverse Events (AE)/endpoint information.

  • Determining initial/update status of incoming events.

  • Database entry.

  • Coding AE and products, writing narratives, and literature-related activities as per internal/project timelines.

• Ensure quality standards are met per project requirements.

• Meet productivity and delivery standards per project requirements.

• Ensure compliance with all project-related processes and activities.

• Read and acknowledge all necessary IQVIA 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.

• Create, maintain, and track cases as applicable to the project plan.

• Identify quality problems, if any, and bring them to the attention of a senior team member.

• Demonstrate problem-solving capabilities.

• Liaise with different functional team members, e.g., project management, clinical, data management, healthcare professionals (e.g., investigators, medical monitors, site coordinators, and designees) to address project-related issues.

• May liaise with clients regarding day-to-day case processing activities.

• Mentor new team members, if assigned by the Manager.

• Attend project team meetings and provide feedback to the operations manager on any challenges/issues or successes.

• Perform other duties as assigned.

• Lead/support department initiatives.

• Ensure 100% compliance with all people practices and processes.

• Depending on the project requirement, perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs), including review of AE coding, past medical history, concomitant medications, expectedness/listedness, causality assessment, and other medical information. Ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines. Communicate with team leads for any corrections required in the case and maintain appropriate documentation for all communications.

Qualifications

• High School Diploma or equivalent in a scientific or healthcare discipline or allied life sciences required.

• Bachelor’s degree in life sciences or related field and up to 3 years of relevant experience, including up to 1 year of pharmacovigilance experience required, or an equivalent combination of education, training, and experience preferred.

• Proficiency in French and English required.

• Good knowledge of medical terminology.

• Working knowledge of applicable safety databases and any other internal/client applications.

• Knowledge of applicable global, regional, and local clinical research regulatory requirements.

• Excellent attention to detail and accuracy.

• Maintain high-quality standards.

• Good working knowledge of Microsoft Office and web-based applications.

• Strong organizational and time management skills.

• Strong verbal and written communication skills.

• Self-motivated and flexible.

• Ability to follow instructions/guidelines, utilize initiative, and work independently.

• Ability to multi-task, meet strict deadlines, manage competing priorities, and changing demands.

• Ability to delegate to less experienced team members.

• Ability to be flexible and receptive to changing process demands.

• Willingness and aptitude to learn new skills across safety service lines.

• Ability to establish and maintain effective communication and working relationships with coworkers, managers, and clients.

• Ability to work as a team player, contribute, and work towards achieving team goals.

• Ensure quality of deliverables according to the agreed terms.

• Demonstration of IQVIA core values while performing daily tasks.

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

• Regular sitting for extended periods.

• May require occasional travel.

• Flexibility to operate in shifts.

#LI-REMOTE

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