Hybrid Safety Reporting Coordinator (FDA/EMA)

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

Benefits offered by this job

Medicover

MultiSport

UNIQUA

PPE at Goldman Sachs and other

Job summary

Pfizer in Warsaw, Poland, is seeking an experienced project manager to lead safety aggregate report preparation for regulatory submissions (FDA/EMA). You will coordinate cross-functional teams across Clinical, Regulatory, Safety, and other lines to ensure timely, compliant reports and provide guidance on report requirements.

The role requires strong English communication, a detail-oriented mindset, and solid project management skills.

Qualifications

• Bachelor's Degree in life sciences, healthcare, or pharmaceutical discipline required.
• Excellent English verbal, written communication and presentation skills required.
• Must be detailed oriented.
• Strong project management and issue resolution skills required.
• Demonstrated ability to perform in a cross-functional environment.
• Knowledge of regulatory/safety regulations and guidelines desired.

Responsibilities

• Lead report preparation from prep to submission with key stakeholders within Clinical, Regulatory, Safety, DevOps, Submissions, etc.
• Review data to ensure consistency between various contributors.
• Compile the information for reports using various electronic tools and document management system.
• Coordinate the review and approval of the report and address review comments.
• Ensure reports are completed prior to regulatory due date to meet compliance.
• Provide guidance to contributor regarding report requirements.
• Participate in developing and performing User Acceptance Testing (UAT) as required.

Skills

Project management

Cross-functional collaboration

Communication

Microsoft Office

Education

Bachelor's Degree in life sciences/healthcare/pharmaceutical

Tools

SharePoint

PDF software (Adobe)

Business Objects/BI

Job description

Pfizer in Warsaw, Poland, is seeking an experienced project manager to lead safety aggregate report preparation for regulatory submissions (FDA/EMA). You will coordinate cross-functional teams across Clinical, Regulatory, Safety, and other lines to ensure timely, compliant reports and provide guidance on report requirements.

The role requires strong English communication, a detail-oriented mindset, and solid project management skills.