Manager, Aggregate Reports Analyst

Position: Manager, Aggregate Reports Analyst

Company: Pfizer

Locations: Multiple (Hybrid)

Level: Mid-Level

Industry: Pharmaceutical, HealthTech, AI, Machine Learning, Medical Writing, Regulatory Affairs

Role Overview

The Manager, Aggregate Reports Analyst plays a key role in authoring and managing safety documents related to post-marketing surveillance. This includes analyzing safety data, preparing regulatory reports, and ensuring compliance with global pharmacovigilance requirements.

Working within Pfizer's Worldwide Safety (PSSR) team, this position collaborates across functions to assess benefit-risk profiles and support the safe use of medicines worldwide.

Key Responsibilities

• Author and coordinate regulatory safety documents such as:
• Development Safety Update Reports (DSURs)
• Periodic Safety Update Reports (PSURs)
• Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Addendum to Clinical Overviews
• Risk Management Plans (RMPs)
• New Drug Application Safety Reports
• Canadian Annual Reports, etc.
• Perform integrated analyses of post-marketing safety data.
• Ensure all documentation complies with global regulatory guidelines and corporate policies.
• Translate complex data into clear, accurate safety narratives for regulatory submission.
• Identify gaps or issues in safety datasets and propose resolution strategies.
• Coordinate with internal project teams and external authors/vendors as needed.
• Review and edit documents produced by contractors and ensure alignment with regulatory standards.
• Collaborate cross-functionally with safety experts, regulatory affairs, and clinical teams.
• Maintain awareness of evolving pharmacovigilance regulations and contribute to process improvements.

Minimum Qualifications

• Bachelor’s degree in Life Sciences or a related field.
• Minimum 3 years of relevant experience in:
• Clinical practice
• Clinical trials or academic medicine
• Pharmaceutical industry (especially safety, regulatory, or clinical areas)

Preferred Qualifications

• Advanced degree (MD, DVM, PharmD, Master’s/PhD in relevant field).
• Strong understanding of benefit-risk assessment and pharmacovigilance principles.
• Experience interpreting and synthesizing individual and aggregate patient safety data.
• Excellent medical writing skills with minimal supervision required.
• Solid knowledge of disease areas and drug mechanisms of action.
• Strong decision-making and analytical skills in moderately complex situations.

Work Environment

• Work Location Assignment: On-premise (Hybrid options may vary by region)
• Collaborative team environment with cross-functional responsibilities in global safety and regulatory reporting.