Safety Aggregate Report Lead – Regulatory Submissions

Pfizer Inc; Województwo mazowieckie; 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 Poland (Warsaw area) is seeking a project management professional to lead safety aggregate report creation for regulators (FDA/EMA). The role partners with safety, clinical, regulatory, and other functions to deliver timely, compliant reports and support the group’s deliverables.

Responsibilities include coordinating with multiple teams, ensuring data consistency, handling reviews and approvals, and participating in UAT and training per Pfizer policies.

Qualifications

• Bachelor’s Degree in life sciences, healthcare, or pharmaceutical discipline required.
• Experience in the pharmaceutical industry, clinical research, or healthcare related field is preferred.
• 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.
• Review data for consistency across contributors.
• Compile information for reports using document management systems.
• Coordinate review and approval of reports and address comments.
• Ensure reports meet regulatory due dates and compliance.
• Provide guidance on report requirements to contributors.
• Participate in projects and tasks supporting the group and deliverables.
• Contribute to User Acceptance Testing (UAT) as required.
• Complete training per Pfizer’s safety information management curriculum.

Skills

Microsoft Office

SharePoint

PDF software

Business Objects

Education

Bachelor’s Degree in life sciences/healthcare/pharmaceutical

Tools

Business Objects

Job description

Pfizer in Poland (Warsaw area) is seeking a project management professional to lead safety aggregate report creation for regulators (FDA/EMA). The role partners with safety, clinical, regulatory, and other functions to deliver timely, compliant reports and support the group’s deliverables.

Responsibilities include coordinating with multiple teams, ensuring data consistency, handling reviews and approvals, and participating in UAT and training per Pfizer policies.