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. The individual will act as primary point of contact providing subject matter expertise to the group and various stakeholders. The individual will act as mentor to new colleagues, providing training and guidance on report coordination tasks and functions and is responsible for the preparation and maintenance of work instructions related to the respective subject matter.

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 as an experienced SME that is available for internal or external queries and support.
• Provide training and act as a mentor to colleagues. 
• Prepare and maintain job aids for use by the group as reference.
• 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 curriculum.

Technical Skill Requirements

Experience with:

• Microsoft Products, (e.g., Word, PowerPoint, Excel, Outlook, Teams) 
• SharePoint technology 
• PDF software (e.g., Adobe)
• Business Objects/Intelligence experience preferred

Qualifications

• Experience in the pharmaceutical industry, clinical research, or healthcare related field with a minimum of 3 years of report coordination experience with clinical safety data and business processes in the pharmaceutical industry, including understanding the drug development process.
• Minimum of a bachelor’s degree in life sciences, healthcare, or a pharmaceutical discipline required.
• Knowledge of regulatory/safety regulations and guidelines.  
• Excellent English verbal, written communication and presentation skills required.
• Strong project management and issue resolution skills required.
• Demonstrated ability to perform in a cross-functional environment. 
• Demonstrated ability to lead.
• Subject Matter Expert (SME) experience preferred.
   

  
Work Location Assignment: Hybrid

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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