Instagram
youtube
Facebook

Manager Aggregate Reports Analyst

3+ years
Not Disclosed
10 Sept. 15, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Job Title

Manager, Aggregate Reports Analyst

Organisation

Pfizer Inc.

Location

  • India – Chennai

  • Philippines – Makati City

  • Full-time

  • Work Location Assignment: On Premise

Job ID

4939121

Posted On

12 days ago


About Pfizer

  • Purpose: Breakthroughs that change patients’ lives through innovation.

  • Values: Defined expectations for what we achieve and how we achieve it.

  • Research & Development: Central to Pfizer’s mission of advancing life-changing medicines.

  • Benefits: Competitive compensation and benefits tailored to diverse employee needs.

  • Culture: “Pfizer, We are One” – collaborative, science-driven, and patient-focused.


Why Patients Need You

The Worldwide Medical and Safety team supports evidence-based medical decision-making to improve health outcomes. By ensuring safety data is scientifically sound and regulatory-compliant, this role empowers healthcare professionals to make informed decisions on the safe and effective use of Pfizer medicines.


Position Purpose

The PSSR Aggregate Report Analyst develops and manages documents related to post-marketing safety data to support:

  • Product development

  • License applications

  • Post-marketing maintenance

These documents include but are not limited to:

  • Aggregate safety reports: DSURs, PSURs, PBRERs

  • Regulatory documents: Addendum to Clinical Overviews, NDA Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports

  • Risk-related documents: Risk Management Plans, post-marketing safety assessments

  • Regulatory responses: Queries and safety-related assessments

Key aspects of the role:

  • Translate regulatory requirements and corporate policies into compliant and timely analyses.

  • Assess document requirements, complexity, and information gaps.

  • Collaborate with project teams to propose solutions for issues.

  • Provide oversight for co-authors (internal or external) when required.


Responsibilities

  • Create, review, and finalize post-marketing aggregate safety reports.

  • Ensure timely and compliant presentation of safety data and benefit–risk assessments.

  • Conduct routine analyses and interpret safety data with guidance from senior team members.

  • Collaborate with project teams to resolve document or data-related issues.

  • Supervise co-authors for specific projects (e.g., Canadian Annual Reports).


Qualifications

Education

  • Bachelor’s degree in Life Sciences with 3+ years relevant medical experience (patient care, clinical trials, academic medicine, specialty training, or pharmaceutical industry).

  • Advanced degree preferred: MD, DVM, PharmD, Master’s, or PhD in a relevant field.

Experience & Attributes

  • Analytical skills: Ability to execute and interpret routine safety analyses.

  • Regulatory knowledge: Strong understanding of global regulatory guidance for benefit–risk and pharmacovigilance.

  • Medical writing skills: Ability to synthesize aggregate/individual patient data into high-quality documents with minimal supervision.

  • Medical knowledge: Understanding of disease concepts and treatment approaches.

  • Decision-making: Capable of resolving moderately complex problems with multiple options.

  • Interpersonal skills: Effective collaboration with cross-functional teams and stakeholders.


Equal Opportunity Statement

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates