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Aggregate Report Analyst Senior Associate

2+ years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Full Time 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

 

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.