Associate - Aggregate Report Coordinator

at  Pfizer

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).
Purpose
Breakthroughs that change patients’ lives… At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Medical

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