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Aggregate Report Analyst Manager

3+ years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Hybrid Education: PharmD, MD, DVM, PhD, or Master’s 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

 

Aggregate Report Analyst Manager – Pfizer

Location: Chennai, India
Job Type: Full-Time
Work Mode: Hybrid


Job Summary

Pfizer is hiring an experienced Aggregate Report Analyst Manager in Chennai to lead the development and delivery of global post-marketing safety documents, including PBRERs, DSURs, RMPs, and other regulatory submissions. This hybrid role involves close collaboration with cross-functional project teams to ensure the timely and compliant preparation of safety documents in support of drug development, licensing, and lifecycle management. You will also provide oversight to internal and external authors and vendors.


Key Responsibilities

  • Prepare integrated analyses of safety data for aggregate reports including PBRERs, DSURs, RMPs, ACOs, and others

  • Serve as point-of-contact for documentation issues across assigned products

  • Manage timelines and ensure compliance with internal SOPs and global regulatory standards

  • Review, edit, and approve documents authored by contractors or team members

  • Lead strategic messaging with project team SMEs on safety data presentation

  • Drive consistent quality and document integrity across all deliverables

  • Build and maintain relationships with internal stakeholders across Pfizer lines

  • Contribute to process improvement initiatives and documentation best practices


Required Skills & Qualifications

  • Bachelor’s degree in Life Sciences (mandatory)

  • Minimum 3 years of relevant medical or pharmaceutical industry experience (e.g., safety, clinical, regulatory)

  • Advanced degree (PharmD, MD, DVM, PhD, or Master’s) preferred

  • Strong understanding of pharmacovigilance regulations (ICH-GCP, GVP)

  • Hands-on experience with aggregate report writing (PBRER, DSUR, RMP)

  • Excellent writing, data analysis, and project coordination skills

  • Ability to manage documentation strategies and vendor oversight

  • Knowledge of MedDRA, safety databases, and regulatory submission tools


Perks & Benefits

  • Competitive compensation package (Exact salary not specified)

  • Flexible hybrid working environment

  • Global exposure to industry-leading safety and regulatory practices

  • Inclusive culture with professional development opportunities

  • Work on breakthrough innovations that impact global patient safety


About Pfizer

Pfizer is a world leader in innovative pharmaceuticals, delivering life-changing medicines that impact millions of patients globally. Its Chennai-based R&D center supports global regulatory and safety documentation, clinical development, and pharmacovigilance operations.


Work Mode

Hybrid – Work flexibility combining in-office presence at Chennai and remote setup.


Call-to-Action

Ready to lead global safety documentation at one of the world’s most respected pharma companies?
Apply now and play a key role in Pfizer’s mission to transform patients’ lives through safety, science, and global collaboration.