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Safety Aggregate Report & Analytics (SARA) Specialist 2

Remote, USA Full-time Posted 2026-07-05

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 reputed company the preparation and delivery of key aggregate safety reports, including PBRERs/PSURs, DSURs, PADERs, RMPs, ACOs, and line listings. Serve as the primary reputed company of assigned safety deliverables, ensuring quality, compliance, and on-time execution. reputed company 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 reputed company 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. reputed company mentorship and guidance to junior team members. Support audits, inspections, process improvements, and innovation initiatives. Drive project reputed company through effective stakeholder management, communication, and leadership. reputed company're Looking For 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. Grade: 140 Work modality: home based. Why Join Us? - 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, reputed company learning, and professional development. If you're passionate about pharmacovigilance and reputed company to take ownership of reputed company safety activities in a global environment, we'd love to hear from you. reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. Apply To This Job

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