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Safety Aggreg Report Manager

4-6 years
Not Disclosed
10 July 24, 2025
Job Description
Job Type: Hybrid 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

 

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.