Position Purpose

• Individual filling the position are responsible for the project management of safety aggregate reports submitted to regulators that include the FDA and EMA.

• The incumbent will partner with various colleagues from Safety, Clinical, Regulatory and other functional lines to produce the aggregate reports and ensure that these reports are completed in a timely manner meeting regulatory compliance.

Primary Responsibilities

• Lead report preparation from prep to submission with key stakeholders/contributors 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 projects or subject matter tasks that support the group and deliverables.

• Participate in developing and performing User Acceptance Testing (UAT) as required.

• Complete training in accordance with Pfizer’s and WSR Safety information Management curriculum.

Technical Skill Requirements

• Experience in the pharmaceutical industry, clinical research, or healthcare related field.

• Experience with Microsoft Word & Excel, Adobe Acrobat, ISI Toolbox, etc.

• Experience with SharePoint technology (e.g., Microsoft InfoPath, SharePoint Designer, etc.)

• Business Objects experience is a plus.

Qualifications (i.e., preferred education, experience, attributes)

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

• Excellent English verbal, written communication and presentation skills required.

• Must be detail-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.

Work Location Assignment:Flexible (hybrid working model: Warsaw site & HO).