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IQVIA is a publicly-traded healthcare intelligence company founded in 2016 upon the merger of two market leaders: Quintiles and IMS Health. With locations aroun
Safety Aggregate Report & Analytics (SARA) Specialist 2
Location
Worldwide
Posted
14 days ago
Salary
0
Seniority
Mid Level
Job Description
Safety Aggregate Report & Analytics (SARA) Specialist 2
IQVIA
Role Description We are seeking a highly motivated pharmacovigilance professional to join our Safety Aggregate Report & Analytics (SARA) team. This is an exciting opportunity to take a leading role in safety reporting, signal management, and benefit-risk evaluation activities supporting both marketed and investigational products worldwide. Working in a highly collaborative and international environment, you will partner with cross-functional stakeholders, advise clients, and contribute directly to the safety strategies that help protect patients across the globe. What You'll Do: - 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, Safety Operations, and other functional teams. - 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. Qualifications - 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.
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