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.
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