Job Title: Safety Aggregate Report Specialist 1
Location: Bengaluru, India (Hybrid)
Job Type: Full Time
Job ID: R1495476
Additional Locations: Available
Company: IQVIA
Job Overview
As a Safety Aggregate Report Specialist 1 (SARA), you will be the principal owner of aggregate safety deliverables, responsible for ensuring timely and compliant completion of reports such as PBRERs, DSURs, and signal management documentation, in line with service level agreements (SLAs) and regulatory expectations.
Key Responsibilities
Aggregate Reporting
Serve as primary author, reviewer, or QCer for safety aggregate reports.
Lead, author, and finalize PBRERs/PSURs, DSURs, PADERs, ACOs, line listings, and device reports.
Author responses to regulatory agencies or Pharmacovigilance Risk Assessment Committee (PRAC) inquiries.
Signal Management
Act as Signal Management Specialist for both post-marketing and clinical trial projects.
Perform signal detection, validation, evaluation, and documentation.
Author signal management deliverables and benefit-risk evaluations.
Participate in Safety Management Teams and contribute to safety strategy.
Literature Surveillance
Lead or support ongoing literature safety surveillance for marketed and investigational products.
Identify ICSRs, evaluate events of special interest, and review aggregate safety data.
Contribute to literature-based deliverables and meet strict regulatory timelines.
Client & Cross-Functional Collaboration
Interface with internal teams such as:
Regulatory Reporting (RR)
Real World Late Phase (RWLP)
Medical Writing, Clinical Research, Quality, IT, PVS, MSA, QPPV, etc.
Respond to client requests and participate in project review meetings.
Communicate project issues and updates to relevant stakeholders.
Provide training and mentorship to junior team members.
Compliance & Quality
Participate in audits and inspections.
Adhere to IQVIA SOPs and client-specific procedures.
Complete all required training in a timely manner.
Project Management Support
Serve as the interface between global project leads and working teams.
Conduct lessons learned sessions and maintain effective communication flow.
Track project metrics, SOW changes, and ensure on-time deliverable submissions.
Technology & Innovation
Support or contribute to internal technology enhancement and innovation initiatives.
Qualifications
|
Requirement |
Level/Detail |
|---|---|
|
Education |
Bachelor's Degree (Required) |
|
Experience |
1–3 years in drug safety, aggregate reporting, signal management, or literature surveillance (Preferred) |
|
Technical Skills |
Proficiency in Microsoft Office (Word, Excel, PowerPoint); web-based tools |
|
Medical Knowledge |
Good knowledge of medical terminology |
|
Communication |
Strong verbal and written communication skills |
|
Soft Skills |
Detail-oriented, self-motivated, organized, flexible |
|
Work Ethic |
Able to follow instructions, manage priorities, and work independently |
|
Training & Development |
Willingness to learn new skills across service lines |
About IQVIA
IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services. We connect data, domain expertise, and technology to drive healthcare forward. Learn more at jobs.iqvia.com
How to Apply
Apply Now
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