Primary Responsibilities:
- Report Management: Lead the preparation, review, and submission of safety aggregate reports, coordinating with key stakeholders across Clinical, Regulatory, Safety, DevOps, Submissions, etc.
- Data Consistency: Ensure consistency of data provided by various contributors.
- Compilation and Documentation: Compile information using electronic tools and document management systems.
- Review Coordination: Oversee the review and approval process of reports, addressing comments as necessary.
- Compliance: Ensure reports are completed and submitted by regulatory due dates.
- Guidance and Support: Provide guidance to contributors on report requirements.
- Project Participation: Engage in projects or subject matter tasks that support the group’s objectives.
- User Acceptance Testing (UAT): Participate in developing and performing UAT as needed.
- Training: Complete training according to Pfizer’s and WSR Safety Information Management curriculum.
