Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities 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)
• Lead, author and finalize aggregate reports
• Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee inquiries
• 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.
• Act as Signal Management Lead on post-marketing and clinical trial projects.

• Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables.

• 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 characterization of risks
• Interface with clients and other functional groups within Lifecycle Safety and other business units
• Participate in internal and external audits and inspections
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
• Provide regular reports to overall project manager and department management on project metrics, changes, client requests or concerns
• Communicate and document project issues to project team members and department management in a timely manner

Qualifications:

• Bachelor's Degree and around 2 - 3 years of relevant work experience
• Excellent knowledge of Lifecycle Safety services and processes

• Good knowledge of medical terminology
• In depth knowledge of applicable global, regional, local regulatory requirements, i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs
• Excellent organizational time-management and prioritizing skills
• Very good attention to detail and accuracy maintaining consistently high quality standards
• Excellent written/verbal communication and report writing skills
• Independent thinking and decision making abilities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

• Ability to work in fast-paced and dynamic environment
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint)

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.