Safety Aggregate Report Manager – Bengaluru (Hybrid)
Salary/Compensation: Not specified in the job description.
Job Summary
IQVIA is looking for a highly skilled Safety Aggregate Report Manager to oversee Safety Aggregate Report and Analytics (SARA) deliverables, including signal detection, literature surveillance, benefit-risk management, and safety reporting. This leadership role requires expertise in pharmacovigilance, regulatory compliance (GVP, ICH-GCP), and cross-functional collaboration to ensure the highest quality in safety documentation and signal management activities for global projects.
Key Responsibilities
Act as global functional lead for aggregate reporting, literature surveillance, and signal management projects.
Author and finalize PBRERs, PSURs, DSURs, PADERs, RMPs, REMS, and line listings.
Lead safety literature reviews, identify ICSRs, and evaluate signal detection relevance.
Manage signal detection strategies, perform signal validation and evaluation, and document findings.
Provide leadership for safety management teams and oversee all signal management deliverables.
Mentor, train, and guide SARA team members to ensure compliance with regulatory timelines and quality standards.
Interface with cross-functional units including regulatory affairs, medical writing, pharmacovigilance support, and IT.
Lead audit preparation and ensure audit-readiness for safety deliverables.
Contribute to continuous process improvement and implementation of operational efficiencies.
Required Skills & Qualifications
Bachelor’s degree in Scientific or Healthcare disciplines.
4–6 years of experience in pharmacovigilance or lifecycle safety operations.
Strong expertise in GCP, GVP, ICH guidelines, and global safety regulations.
Experience authoring regulatory safety documents and managing safety signal detection.
Excellent project management, leadership, and mentoring skills.
Strong analytical and problem-solving capabilities.
Exceptional written and verbal communication skills.
Perks & Benefits
Opportunity to lead global safety reporting initiatives.
Hybrid work model with flexible work arrangements.
Career advancement through specialized pharmacovigilance training and mentorship.
Exposure to cutting-edge drug safety technologies and regulatory processes.
Company Description
IQVIA is a global leader in clinical research, healthcare intelligence, and real-world data, helping life sciences companies accelerate the development and delivery of innovative therapies. Through advanced analytics and expert insights, IQVIA improves patient outcomes and safety worldwide.
Work Mode: Hybrid – Bengaluru, India
Call-to-Action
Advance your career in pharmacovigilance and safety reporting with IQVIA. Apply today to become the Safety Aggregate Report Manager and lead global safety initiatives.
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