Associate – Aggregate Report Coordinator
Location: Chennai, India (Hybrid)
Employment Type: Full-Time
Job Requisition ID: 4949842
Posted: 2 Days Ago
Position Overview
We are seeking an experienced Associate – Aggregate Report Coordinator to join our safety and regulatory team in Chennai. The incumbent will manage the preparation and submission of safety aggregate reports to global regulatory authorities, including the FDA and EMA. This role requires collaboration across Clinical, Regulatory, Safety, DevOps, and Submissions teams to ensure timely, accurate, and compliant reporting in alignment with regulatory requirements.
This role is ideal for professionals with 2–5 years of experience in pharmacovigilance, clinical research, or pharmaceutical regulatory operations, with strong project management skills and familiarity with safety reporting processes.
Key Responsibilities
Lead the end-to-end preparation of aggregate safety reports, coordinating with key stakeholders across Clinical, Regulatory, Safety, DevOps, and Submissions teams.
Review and reconcile data to ensure consistency and accuracy across multiple contributors.
Compile, format, and manage report content using electronic tools and document management systems.
Coordinate report review, approvals, and resolution of comments from contributors and stakeholders.
Ensure all reports are completed prior to regulatory due dates to maintain compliance.
Provide guidance to contributors on report requirements, standards, and best practices.
Participate in projects or subject-matter tasks that support group deliverables.
Assist in User Acceptance Testing (UAT) and system validation as required.
Complete all training per Pfizer’s Safety Information Management curriculum.
Technical Skills & Tools
Experience in Microsoft Word, Excel, Adobe Acrobat, ISI Toolbox, and document management systems.
Familiarity with SharePoint technology (InfoPath, SharePoint Designer) for report management.
Knowledge of Business Objects or other reporting tools is a plus.
Strong project management, issue resolution, and cross-functional collaboration skills.
Required Qualifications & Experience
Bachelor’s Degree in Life Sciences, Healthcare, or Pharmaceutical discipline required.
2–5 years of experience in pharmacovigilance, clinical research, or regulatory reporting.
Excellent English communication skills, both written and verbal, with strong presentation abilities.
High attention to detail and accuracy in report preparation.
Knowledge of global regulatory and safety reporting requirements is desirable.
Ability to perform effectively in a cross-functional, collaborative environment.
Why Join
Contribute to global safety and regulatory compliance supporting patient health.
Work in a hybrid model with exposure to international regulatory teams.
Opportunity to enhance pharmacovigilance expertise and career growth in clinical operations and regulatory affairs.
Be part of a leading pharmaceutical organization committed to innovation, inclusion, and quality.
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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