Senior Safety Aggregate Reporting Specialist – IQVIA, Warsaw
Job Summary
IQVIA, a global leader in healthcare intelligence and clinical research services, is hiring a Senior Safety Aggregate Reporting Specialist in Warsaw. This pivotal role involves end-to-end responsibility for safety aggregate deliverables, signal detection, risk management documentation, and regulatory reporting. Ideal for experienced pharmacovigilance professionals aiming to lead post-marketing and clinical trial safety activities.
Key Responsibilities
Serve as the primary owner for Safety Aggregate Report and Analytics (SARA) deliverables ensuring SLA compliance.
Lead signal detection activities, including validation and evaluation for proactive risk identification.
Author and finalize aggregate safety reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, ACOs, and line listings.
Conduct continuous literature surveillance for marketed and investigational products.
Support the identification and evaluation of ICSRs and aggregate data review.
Collaborate with clients, Lifecycle Safety teams, and cross-functional departments.
Prepare regulatory response documents, including PRAC inquiries.
Participate in audits and inspections as required.
Contribute to departmental productivity and utilization goals.
Required Skills & Qualifications
Bachelor's Degree in a scientific or healthcare field or equivalent training.
2–3 years of pharmacovigilance or related drug safety experience.
In-depth knowledge of Lifecycle Safety processes and global regulatory guidelines.
Proficiency with Microsoft Office and web-based tools.
Strong attention to detail with excellent accuracy and quality standards.
Ability to manage tight deadlines and multiple priorities.
Excellent communication and technical writing skills.
Self-driven, adaptable, and collaborative team player.
Perks & Benefits
Opportunity to work with a global healthcare leader.
Exposure to diverse clinical trial and post-marketing projects.
Professional development in advanced pharmacovigilance practices.
Collaborative and dynamic work environment.
About IQVIA
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Their expertise helps accelerate medical innovation and improve healthcare outcomes worldwide.
Work Mode: On-site – Warsaw
Call to Action:
If you are ready to elevate your pharmacovigilance career with a global healthcare innovator, apply now at IQVIA Careers.
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