Safety Aggregate Reports Lead (Regulatory)

Pfizer; Warszawa; Hybrid; PLN 90,000 - 111,000; Full time

Benefits offered by this job

Medicover

MultiSport

UNIQUA

PPE at Goldman Sachs and other Pfizer-

Job summary

Pf Pfizer Polska in Warsaw seeks a project-driven professional to manage regulatory safety aggregate reports for FDA/EMA, coordinating with Clinical, Regulatory, Safety and DevOps teams. You will ensure timely, compliant submissions and guide contributors on report requirements within a hybrid work setting.

The role emphasizes cross-functional collaboration, attention to detail, and strong project management in a life sciences or pharmaceutical environment. English fluency is essential.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or pharmaceutical discipline is required.
• Excellent English verbal and written communication skills are required.
• Experience in pharmaceutical industry or healthcare-related field is preferred.

Responsibilities

• Lead report preparation from prep to submission with key stakeholders within Clinical, Regulatory, Safety, DevOps and Submissions.
• Review data to ensure consistency between contributors.
• Compile information for reports using various electronic tools and document management systems.
• Coordinate review and approval of reports and address review comments.
• Ensure reports are completed prior to regulatory due dates to meet compliance.
• Provide guidance to contributors regarding report requirements.
• Participate in projects or tasks supporting the group and deliverables.
• Participate in UAT as required.

Skills

Project management

English

Attention to detail

Cross-functional collaboration

Education

Bachelor’s Degree in life sciences, healthcare, or pharmaceutical discipline

Tools

SharePoint

Microsoft Office

PDF software

Business Intelligence

Job description

Pf Pfizer Polska in Warsaw seeks a project-driven professional to manage regulatory safety aggregate reports for FDA/EMA, coordinating with Clinical, Regulatory, Safety and DevOps teams. You will ensure timely, compliant submissions and guide contributors on report requirements within a hybrid work setting.

The role emphasizes cross-functional collaboration, attention to detail, and strong project management in a life sciences or pharmaceutical environment. English fluency is essential.