Safety Aggregate Report Specialist – Bengaluru
Job Summary:
IQVIA is hiring a Safety Aggregate Report Specialist (SARA Specialist) in Bengaluru for pharmacovigilance, aggregate reporting, and literature safety surveillance. The role involves authoring PBRERs, PSURs, DSURs, PADERs, and signal management deliverables. Ideal for professionals with 1–3 years of experience in drug safety and regulatory reporting, this position offers a hybrid work mode with opportunities to lead critical safety deliverables for global projects.
Key Responsibilities:
Lead, author, and finalize aggregate reports (PBRERs, PSURs, DSURs, PADERs, ACOs, device reports, and line listings).
Conduct literature surveillance, identify ICSRs, and evaluate events of special interest.
Manage signal detection, validation, evaluation, and documentation for risk characterization.
Author regulatory responses and labeling justification documents.
Collaborate with cross-functional teams (Regulatory Reporting, Medical Writing, Quality, Safety Operations).
Participate in audits, inspections, and project review meetings.
Mentor and train junior safety associates on aggregate reporting and PV processes.
Support technology and innovation initiatives to enhance lifecycle safety services.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences or Healthcare discipline.
1–3 years of experience in pharmacovigilance, aggregate reporting, signal management, or literature surveillance.
Strong understanding of GVP, ICH, and regulatory guidelines.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and safety database tools.
Excellent communication, data review, and report writing skills.
Ability to manage competing priorities and strict regulatory timelines.
Attention to detail, accuracy, and self-motivation with the ability to work independently.
Perks & Benefits:
Opportunity to work with global drug safety and pharmacovigilance experts.
Professional growth through advanced training programs.
Exposure to critical regulatory safety deliverables across multiple therapeutic areas.
Hybrid work model with flexible collaboration opportunities.
Company Description:
IQVIA is a global leader in clinical research, healthcare analytics, and pharmacovigilance solutions, supporting life sciences companies worldwide to bring innovative treatments to market. With a focus on regulatory compliance and patient safety, IQVIA accelerates drug development and commercialization.
Work Mode: Hybrid – Bengaluru, India.
Call-to-Action:
Take the next step in your pharmacovigilance career. Apply now to join IQVIA as a Safety Aggregate Report Specialist in Bengaluru.
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