Report Coordinator Associate

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 with:

• Microsoft Products, (e.g., Word, PowerPoint, Excel, Outlook, Teams)
• SharePoint technology
• PDF software (e.g., Adobe)

Business Objects/Business Intelligence experience is a plus.

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

• 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. 
  

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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