Job Title: Associate – Aggregate Report Coordinator (Safety & Pharmacovigilance)
Location: Chennai, India
Employment Type: Full-Time | Hybrid
Job Requisition ID: 4949842
Pfizer is seeking an Associate – Aggregate Report Coordinator to support global pharmacovigilance and regulatory compliance activities. This role is responsible for the end-to-end project management of safety aggregate reports submitted to global health authorities, including the FDA and EMA.
The Associate will collaborate with cross-functional teams across Clinical, Regulatory, Safety, Submissions, and Development Operations to ensure that aggregate safety reports are accurate, complete, and submitted on time in compliance with global regulatory requirements. This position is ideal for professionals looking to build a career in drug safety, aggregate reporting, and regulatory operations within a global pharmaceutical environment.
Lead safety aggregate report activities from preparation through final regulatory submission
Coordinate with internal stakeholders across Clinical, Regulatory, Safety, DevOps, and Submissions teams
Review and reconcile data inputs to ensure consistency and accuracy across contributors
Compile report content using electronic tools and document management systems
Manage review and approval workflows, including incorporation and resolution of reviewer comments
Ensure timely completion of reports ahead of regulatory submission deadlines
Provide guidance to contributors on report structure, content requirements, and timelines
Support departmental initiatives, special projects, and subject matter activities
Participate in User Acceptance Testing (UAT) activities for systems and process enhancements
Complete all required training in accordance with Pfizer and WSR Safety Information Management curricula
Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, or a related discipline
Strong proficiency in English with excellent written, verbal, and presentation skills
High attention to detail with strong documentation and quality review capabilities
Minimum Experience:
2–4 years of relevant experience in the pharmaceutical industry, clinical research, pharmacovigilance, or healthcare-related roles
Prior experience in aggregate safety reporting, regulatory submissions, or safety operations is preferred
Strong project management, coordination, and issue resolution skills
Proven ability to work effectively in cross-functional and matrix-driven environments
Hands-on experience with Microsoft Word, Excel, Adobe Acrobat, and document management tools
Familiarity with ISI Toolbox and SharePoint technologies (e.g., InfoPath, SharePoint Designer)
Experience with Business Objects is an advantage
Working knowledge of global safety and regulatory guidelines (FDA, EMA, ICH) is desirable
Hybrid work model based in Chennai, India
Pfizer is an equal opportunity employer and complies with all applicable employment and non-discrimination laws in all jurisdictions in which it operates.
This Associate – Aggregate Report Coordinator role offers the opportunity to work on high-impact global safety deliverables, collaborate with international stakeholders, and strengthen expertise in pharmacovigilance and regulatory compliance.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Kyiv |Lima Region :
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