Safety Aggregate Report & Analytics Specialist 2

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Lead the preparation and delivery of key aggregate safety reports, including PBRERs/PSURs, DSURs, PADERs, RMPs, ACOs, and line listings. • Serve as the primary owner of assigned safety deliverables, ensuring quality, compliance, and on-time execution. • Lead signal management activities, including signal detection, validation, and evaluation. • Risk assessment and characterization. • Documentation and tracking of safety signals. • Development and execution of signaling strategies. • Conduct and oversee literature surveillance for commercialized and investigational products. • Author responses to regulatory authority inquiries and support safety labeling and benefit-risk documentation. • Collaborate with global stakeholders across Pharmacovigilance, Regulatory Affairs, Medical Writing, Clinical Research, Quality, and Safety Operations. • Provide mentorship and guidance to junior team members. • Support audits, inspections, process improvements, and innovation initiatives. • Drive project success through effective stakeholder management, communication, and leadership.

🎯 Requirements

• Bachelor's degree in Life Sciences field. • 2-4 years of post-marketing pharmacovigilance experience covering aggregate reporting, signal management and benefit-risk assessment. • Excellent level of English. • Strong understanding of global pharmacovigilance regulations and guidelines, including GVP, GCP, and ICH. • Experience authoring or leading aggregate safety reports and regulatory deliverables. • Strong project management and stakeholder management skills. • Excellent analytical thinking, attention to detail, and written communication abilities. • Ability to work independently while managing multiple priorities in a fast-paced global environment.

🏖️ Benefits

• Work on high-impact global safety programs that contribute directly to patient safety. • Collaborate with international teams and leading pharmaceutical and biotech clients. • Expand your expertise across aggregate reporting, signal management, risk management, and regulatory strategy. • Grow your leadership skills through mentorship, client interaction, and project ownership. • Be part of a team that values innovation, continuous learning, and professional development.