Aggregate Report Analyst – Senior Associate
Location: Chennai, India
Job Type: Full-Time
Work Mode: Hybrid
Job Summary
Pfizer is hiring an experienced Aggregate Report Analyst – Senior Associate in Chennai to support global safety and regulatory documentation. In this hybrid role, you will be responsible for authoring, reviewing, and managing aggregate safety reports including PBRERs, DSURs, RMPs, and more. Your work will support license applications and post-marketing safety updates, ensuring compliance with evolving pharmacovigilance regulations.
Key Responsibilities
Prepare and deliver high-quality aggregate safety documents (e.g., PBRERs, DSURs, RMPs)
Collaborate with global teams on regulatory strategies and timelines
Interpret safety data and provide clear, concise analysis in regulatory documents
Monitor project progress and proactively address information gaps or delays
Oversee internal and external contributors/vendors on assigned projects
Ensure compliance with internal SOPs and external regulatory guidance
Build strong cross-functional relationships with global teams
Identify and recommend process improvements for document development
Required Skills & Qualifications
Bachelor’s degree in Life Sciences with 2+ years of relevant experience
Advanced degrees (MD, PharmD, PhD, DVM, or Master’s in related fields) preferred
Experience in safety, regulatory affairs, or clinical development
Knowledge of regulatory safety documentation and pharmacovigilance
Proficiency in writing and interpreting aggregate safety data
Understanding of medical terminology and benefit-risk evaluation
Strong project and vendor management skills
Perks & Benefits
Competitive compensation structure
Hybrid work flexibility (office and remote mix)
Access to world-class learning & development opportunities
Inclusive culture focused on innovation in healthcare
Exposure to global regulatory processes and teams
About Pfizer
Pfizer is a global leader in biopharmaceutical innovation, transforming healthcare through advanced clinical research, drug safety, and regulatory excellence. With operations in Chennai, Pfizer supports global development and post-marketing safety strategy for its expansive drug portfolio.
Work Mode
Hybrid – Partial work-from-home flexibility with office presence in Chennai.
Call-to-Action
Take your pharmacovigilance and regulatory writing skills to the next level. Join Pfizer’s global safety team today.
Apply now and be part of breakthroughs that change patients’ lives.
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