REPORT COORDINATOR ASSOCIATE
Company: Pfizer
Location: Chennai, India
Department: Worldwide Safety & Regulatory (WSR) / Pharmacovigilance Operations
Job Type: Full-Time
Work Mode: Hybrid
JOB OVERVIEW
Pfizer is seeking a Report Coordinator Associate to manage the preparation, coordination, review, and submission of global safety aggregate reports to regulatory authorities such as the FDA and EMA. The role involves cross-functional collaboration with Safety, Clinical, Regulatory, Submissions, and Development teams to ensure regulatory compliance and timely report submissions.
KEY RESPONSIBILITIES
Safety Aggregate Report Management
Lead aggregate safety report preparation from initiation through final submission.
Coordinate report activities with stakeholders across:
Safety
Clinical Operations
Regulatory Affairs
DevOps
Submission Teams
Ensure reports are completed within regulatory timelines.
Project Coordination
Act as the primary coordinator for assigned safety reports.
Track report progress and timelines.
Identify risks and proactively resolve issues affecting submissions.
Facilitate communication among cross-functional teams.
Data Review & Quality Control
Review data from multiple contributors for consistency and completeness.
Verify accuracy of report content before review and submission.
Ensure compliance with regulatory requirements and internal standards.
Address discrepancies and coordinate corrections.
Documentation & Report Compilation
Compile report information using electronic systems and document management platforms.
Manage report versions and document control activities.
Utilize Microsoft Office and PDF software for report preparation.
Review & Approval Management
Coordinate review cycles and approval processes.
Consolidate reviewer comments and feedback.
Ensure comments are resolved before final submission.
Facilitate stakeholder sign-off and document approvals.
Regulatory Compliance
Ensure all reports meet FDA, EMA, and global regulatory requirements.
Maintain submission compliance and audit readiness.
Support regulatory inspections and audits when required.
Process Improvement & System Support
Participate in departmental projects and continuous improvement initiatives.
Support User Acceptance Testing (UAT) activities for new systems and processes.
Assist in optimizing reporting workflows and documentation practices.
Training & Development
Complete mandatory Pfizer training programs.
Maintain knowledge of pharmacovigilance regulations and reporting requirements.
Stay updated on regulatory guidance and reporting standards.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor’s Degree in:
Life Sciences
Pharmacy
Biotechnology
Microbiology
Biochemistry
Healthcare-related disciplines
EXPERIENCE
Preferred
Experience in:
Pharmaceutical Industry
Clinical Research
Pharmacovigilance
Drug Safety
Regulatory Affairs
Healthcare Operations
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