Aggregate Report Analyst Sr. Associate

Data Science Jobs

Warsaw, Poland
Hybrid
Aggregate safety data analysis
Regulatory submission document creation
Benefit-risk assessment
The Aggregate Report Analyst Sr. Associate position at Pfizer in Warsaw, Poland, focuses on creating and managing documents related to post-marketing safety data for pharmaceutical products. The role requires strong analytical and writing skills, along with an understanding of regulatory guidelines and the ability to collaborate with project teams

Job Summary

  • The Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance.
  • Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents.
  • Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts.

Matching Summary

Match Score: 85

The Aggregate Report Analyst Sr. Associate position at Pfizer in Warsaw, Poland, focuses on creating and managing documents related to post-marketing safety data for pharmaceutical products. The role requires strong analytical and writing skills, along with an understanding of regulatory guidelines and the ability to collaborate with project teams.

Skills & Requirements

Must-have

  • Aggregate safety data analysis
  • Regulatory submission document creation
  • Benefit-risk assessment
  • Pharmacovigilance regulatory guidance
  • Scientific writing
  • Data analysis and interpretation

Nice-to-have

  • Process improvement identification
  • Cross-functional global team collaboration
  • Vendor document production oversight
  • Epidemiologic principles familiarity

Key Requirements

  • Bachelor's Degree in life sciences
  • 2+ years relevant medical experience
  • High fluency in written English
  • Strong functional fluency in spoken English
  • Familiarity with global regulatory guidance (ICH, FDA, EMA)

Work Rights

Not specified

Tailored Resume

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