- 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.
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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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