Senior Aggregate Report Coordinator Expert
6 days ago
About Pfizer
Pfizer is a world-renowned pharmaceutical company that puts patients at the forefront of everything we do.
Salary Range: $80,000 - $110,000 per year
The successful candidate will be responsible for managing safety aggregate reports submitted to regulatory bodies, including the FDA and EMA. They will work closely with colleagues from safety, clinical, regulatory, and other functional lines to produce high-quality reports that meet regulatory compliance.
Key Responsibilities:
- Lead report preparation from start to finish, collaborating with key stakeholders and contributors from Clinical, Regulatory, Safety, DevOps, Submissions, and other departments.
- Review data to ensure consistency between various contributors and compile information for reports using electronic tools and document management systems.
- Coordinate review and approval of reports, addressing comments and ensuring timely completion prior to regulatory due dates.
- Provide guidance to contributors on report requirements and participate in projects or subject matter tasks that support the group and deliverables.
- Participate in User Acceptance Testing (UAT) as required and complete training in accordance with Pfizer's and WSR Safety Information Management curriculum.
Technical Skills:
- Experience in the pharmaceutical industry, clinical research, or healthcare-related field.
- Familiarity with Microsoft Word & Excel, Adobe Acrobat, ISI Toolbox, and SharePoint technology, including Microsoft InfoPath and SharePoint Designer.
- Bonus points for Business Objects experience.
Qualifications:
- Bachelor's Degree in life sciences, healthcare, or pharmaceutical discipline required.
- Excellent English verbal, written communication, and presentation skills necessary.
- Must be detail-oriented, with strong project management and issue resolution skills.
- Demonstrated ability to perform in a cross-functional environment.
- Knowledge of regulatory/safety regulations and guidelines desired.
Work Location Assignment: Flexible
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