Associate – Aggregate Report Coordinator (Pharmacovigilance & Drug Safety)
Location: Chennai, India (Hybrid)
Employment Type: Full-Time
Company: Pfizer
About the Role
Pfizer is hiring an Associate – Aggregate Report Coordinator to support global Pharmacovigilance and Drug Safety operations. This role is responsible for end-to-end safety aggregate report management, including PSUR, PBRER, DSUR, FDA and EMA regulatory submissions.
The position acts as a central project coordinator between Clinical Research, Regulatory Affairs, Safety, Submissions, and Global Drug Safety teams to ensure regulatory-compliant, accurate, and timely delivery of global safety reports.
If you are looking to build a long-term career in Aggregate Reporting, Regulatory Pharmacovigilance, and Global Safety Operations, this role sits right at the heart of it.
Key Responsibilities – Aggregate Reporting & Regulatory Compliance
Manage the full lifecycle of safety aggregate reports from preparation to regulatory submission
Coordinate with Clinical, Regulatory Affairs, Pharmacovigilance, Safety Data Management, and Submissions teams
Ensure data consistency across clinical trial data, safety databases, and regulatory documents
Compile and format PSUR, PBRER, DSUR and other aggregate safety reports using electronic document management systems
Manage review cycles, quality checks, and approval workflows
Ensure on-time submission to global health authorities including FDA, EMA, MHRA and other regulatory agencies
Provide guidance to contributors on ICH, GVP, and regulatory reporting requirements
Participate in process improvement projects, inspections, and audit readiness activities
Support User Acceptance Testing (UAT) for safety reporting systems and tools
Complete all mandatory Pfizer Safety Information Management and Pharmacovigilance training
Technical & System Skills
Experience in Pharmaceutical Industry, Clinical Research, Drug Safety or Pharmacovigilance
Hands-on experience with:
Microsoft Word & Excel
Adobe Acrobat
ISI Toolbox or similar aggregate reporting tools
Safety document management systems
Working knowledge of SharePoint, InfoPath, and SharePoint Designer
Business Objects or reporting database tools is an advantage
Qualifications & Professional Requirements
Bachelor’s Degree in Life Sciences, Pharmacy, Biotechnology, Healthcare, or related discipline
Strong written and spoken English communication for global regulatory reporting
High attention to detail with strong quality and compliance mindset
Proven project management, coordination, and deadline-driven execution skills
Ability to work in a cross-functional global pharmacovigilance environment
Knowledge of ICH guidelines, GVP modules, FDA & EMA safety reporting regulations preferred
Why This Role Is Critical in Pharmacovigilance
Safety aggregate reports like PSUR, PBRER and DSUR directly influence how regulators evaluate the benefit-risk profile of medicines worldwide. This role ensures that data from clinical trials, post-marketing surveillance, and safety databases is converted into regulatory-compliant, scientifically accurate, and inspection-ready reports.
You are not just submitting documents — you are safeguarding patient safety on a global scale.
Work Model
Hybrid – Chennai, India
Pfizer is an Equal Opportunity Employer.
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