This is a full-time, regular, 100% home-based role
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 specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.
Essential Functions
- Process safety data in compliance with regulations, SOPs, and project requirements.
- Perform pharmacovigilance activities:
- Collect and track Adverse Events (AEs) and endpoint information.
- Determine event status, enter data into databases, code AEs/products, and write narratives.
- Conduct literature searches, quality reviews, reconciliation, and case closure.
- Assess safety data for reportability and ensure timely reporting to regulatory authorities and stakeholders.
- Maintain project documentation, templates, and workflows.
- Monitor project metrics, timelines, and deliverables; provide regular updates to management.
- Ensure compliance with quality standards and project processes.
- Collaborate with cross-functional teams (clinical, data management, project management) and healthcare professionals.
- Participate in client communications regarding day-to-day project activities.
- Train and mentor junior team members; support team development.
- Contribute to process improvements and efficiency initiatives.
- Complete all required training and maintain compliance with SOPs.
- Attend project meetings and provide feedback on operational performance.
- Perform other duties as assigned.
Qualifications
- Bachelor's Degree in life sciences (mandatory)
- English Advanced (mandatory)
- Up to 5 years of relevant pharmacovigilance experience, inclusive of up to 3 years of specific experience in data entry inside Argus and narrative writing inside case processing activities (mandatory)
- In depth knowledge and understanding of applicable ARGUS Safety Database and any other internal/Client applications.
- In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements.
- Excellent organizational skills, time management skills, attention to detail and accuracy.
- Excellent working knowledge of Microsoft Office and web-based applications.
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