As a Senior Safety Aggregate Reporting Specialist, you will apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including signal management activities, safety aggregate reports, literature surveillance, and benefit risk management documents.
Main Responsibilities
• Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
• Act as Signal Management Lead on post-marketing and clinical trial projects.
• Lead ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks.
• Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings.
• Conduct ongoing literature safety surveillance for marketed and investigational products.
• Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
• Interface with Client and other functional groups within Lifecycle Safety and other business units.
• Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Participate in internal and external audits and inspections, as required.
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Required Skills and Qualifications
• Bachelor's Degree in a Scientific or Healthcare discipline.
• Equivalent combination of education and training.
• Around 2 - 3 years of prior relevant work experience.
• Excellent knowledge of Lifecycle Safety services and processes as well as understanding of applicable global, regional, local regulatory requirements.
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint).
• Excellent attention to detail and accuracy maintaining consistently high-quality standards.
• Proven ability to meet strict deadlines and manage competing priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Self-motivated and flexible.
• Excellent written/verbal communication and report writing skills.
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
