Safety Aggregate Report & Analytics (SARA) Specialist 2
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AI Summary
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.
What We'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, continuous learning, and professional development.
If you're passionate about pharmacovigilance and ready to take ownership of complex safety activities in a global environment, we'd love to hear from you.
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All 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 discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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