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
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