Safety Aggregate Reporting Associate (Hybrid, Warsaw)

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

Benefits offered by this job

Medicover

MultiSport

UNIQUA

Pfizer Pay Policy

Job summary

Pfizer Inc in Warsaw, Poland is seeking a Safety Aggregate Report Coordinator Associate to manage regulatory aggregate report submissions. You will coordinate cross-functional teams across safety, clinical, regulatory, and DevOps to ensure timely, compliant reports.

Responsibilities include leading report prep, data review for consistency, and coordinating review and approval, with emphasis on meeting due dates and regulatory expectations. Hybrid work arrangement offered.

Qualifications

• Bachelor’s Degree in life sciences, healthcare, or pharmaceutical discipline required.
• Experience in the pharmaceutical industry, clinical research, or healthcare related field preferred.
• Excellent English verbal, written communication and presentation skills required.
• Must be detailed oriented.
• Strong project management and issue resolution skills.
• Demonstrated ability to work 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 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.
• Complete training in accordance with Pfizer’s and WSR Safety information Management curriculum.

Skills

Attention to detail

Project management

Cross-functional collaboration

Regulatory knowledge

English communication

Education

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

Tools

Microsoft Office

SharePoint

PDF software

Business Objects

Job description

Pfizer Inc in Warsaw, Poland is seeking a Safety Aggregate Report Coordinator Associate to manage regulatory aggregate report submissions. You will coordinate cross-functional teams across safety, clinical, regulatory, and DevOps to ensure timely, compliant reports.

Responsibilities include leading report prep, data review for consistency, and coordinating review and approval, with emphasis on meeting due dates and regulatory expectations. Hybrid work arrangement offered.