Instagram
youtube
Facebook

Safety Aggreg Report Manager

4-6 years
₹15 – ₹22 LPA
10 July 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Location: Bangalore, India (Pan India applicants eligible)
Position: Safety Aggregate Report Manager
Experience Required: 4–6 years
Company: IQVIA
Job Type: Full-Time
Job Requisition ID: R1495179
Application Deadline: August 29, 2025

About IQVIA:
IQVIA is a global leader in human data science, providing advanced analytics, clinical research services, and cutting-edge technology solutions to accelerate innovation in life sciences and healthcare. We are committed to improving patient outcomes and transforming global health through data-driven insights.

Role Overview:
We are seeking a highly skilled Safety Aggregate Report Manager to function as a global functional lead on pharmacovigilance projects under IQVIA’s Safety Aggregate Report and Analytics (SARA) Center. The role involves overseeing aggregate safety reporting, signal management, literature surveillance, and benefit-risk documentation.

Key Responsibilities:

  • Serve as a standalone global lead for aggregate reporting, signal management, or literature surveillance projects.

  • Author and finalize key pharmacovigilance documents: PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and regulatory responses.

  • Conduct ongoing literature safety surveillance and signal detection/review activities.

  • Lead and organize safety management teams and implement signaling strategies.

  • Perform signal detection, validation, and evaluation activities; ensure documentation and regulatory compliance.

  • Provide consultative support and training to project teams and mentor junior staff.

  • Interface with cross-functional units like Regulatory Affairs, Medical Writing, Clinical Research, and IT.

  • Contribute to audits, SOP compliance, quality check processes, and continuous process improvements.

  • Participate in project review meetings, client interactions, and strategic planning with department leadership.

  • Maintain operational metrics, KPIs, project trackers, and provide audit readiness support.

Candidate Requirements:

  • Bachelor’s degree in a Scientific or Healthcare discipline (Life Sciences, Pharmacy, etc.).

  • 4–6 years of experience in pharmacovigilance, specifically in aggregate report writing or signal management.

  • In-depth knowledge of global PV regulations (GVP, ICH-GCP), safety legislations, and audit practices.

  • Proven experience with tools and methodologies for safety data mining and documentation.

  • Exceptional leadership, project management, mentoring, and client-interfacing capabilities.

  • Strong organizational, communication, and time-management skills.

  • Ability to manage competing priorities and meet tight deadlines.

What We Offer:

  • The opportunity to lead global safety reporting projects with a high-impact team.

  • Work from Bangalore or other locations across India with a flexible work model.

  • Exposure to a world-class pharmacovigilance ecosystem and mentorship opportunities.

  • A growth-oriented work environment focused on operational excellence and innovation.

How to Apply:
Apply via
IQVIA Careers or send your CV to pavan.cm@iqvia.com.

Estimated Salary: ₹15 – ₹22 LPA (based on industry benchmarks for pharmacovigilance management roles in India with 4–6 years of experience)