Pfizer is seeking an Aggregate Report Coordinator for its team in Chennai, India. The position requires a Bachelor’s degree in life sciences, healthcare, or pharmaceutical discipline, excellent communication and presentation skills, and attention to detail.
Job description; The coordinator will be responsible for project management of safety aggregate reports, partnering with colleagues from various functional lines to produce reports and ensure regulatory compliance. The role involves leading report preparation, reviewing data, compiling information, coordinating reviews and approvals, and guiding contributors. The coordinator will also participate in developing and performing user acceptance testing and completing required training.
Associate – Aggregate Report Coordinator
locations; India – Chennai
time type; Full time
job requisition id; 4882350
The individuals filling the position are responsible for the project management of safety aggregate reports submitted to regulators, including 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 promptly, meeting regulatory compliance.
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 systems.
Coordinate the review and approval of the report and address review comments.
Ensure reports are completed before the regulatory due date to meet compliance.
Guide 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 by 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.)