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Manager Aggregate Reports Analyst

3+ years
₹15,00,000 – ₹24,00,000 per annum
10 Aug. 13, 2025
Job Description
Job Type: Full Time 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

Manager – Aggregate Reports Analyst
Location: Chennai, India / Makati City, Philippines

Company Overview:
Pfizer is a global leader in biopharmaceutical innovation, dedicated to breakthroughs that change patients’ lives. With a strong commitment to safety, regulatory compliance, and scientific excellence, Pfizer drives the development and maintenance of life-changing medicines worldwide.

Why Join Pfizer:

  • Play a pivotal role in regulatory safety reporting and post-marketing surveillance.

  • Collaborate with global experts in medical safety, clinical research, and regulatory affairs.

  • Competitive pay, benefits, and professional development opportunities.

  • Inclusive culture with a clear mission to improve health outcomes globally.

Position Summary:
The Manager – Aggregate Reports Analyst is responsible for developing high-quality regulatory documents that communicate safety data, benefit-risk assessments, and post-marketing findings for Pfizer products. This role ensures compliance with global pharmacovigilance regulations, coordinates with cross-functional teams, and delivers accurate, timely, and scientifically sound safety reports for regulatory submission.

Key Responsibilities:

  • Author and review aggregate safety reports, including DSURs, PSURs, PBRERs, Safety Update Reports, Risk Management Plans, and related documents.

  • Synthesize and present post-marketing safety data in alignment with regulatory requirements and corporate policies.

  • Respond to regulatory authority queries related to product safety.

  • Collaborate with project teams to assess document requirements, identify information gaps, and develop resolution strategies.

  • Provide oversight for internal or external contributors involved in safety document preparation.

  • Ensure consistency, accuracy, and clarity in all benefit-risk and safety communications.

Qualifications:

  • Bachelor’s degree in Life Sciences with at least 3 years of relevant medical, clinical, regulatory, or pharmaceutical safety experience.

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

  • Strong understanding of regulatory guidance on benefit-risk assessment and pharmacovigilance.

  • Proven ability to synthesize complex medical and safety data into clear, compliant documents.

  • Analytical skills for interpreting safety data and solving moderately complex problems.

  • Strong written communication skills and attention to detail.

Salary Range:
India: ₹15,00,000 – ₹24,00,000 per annum (estimated)
Philippines: ₱1,800,000 – ₱2,600,000 per annum (estimated)