Aggregate Report Analyst Manager – Chennai
Location: Chennai, India
Work Mode: On-site (Full-time)
Salary/Compensation: Not specified in the job description
Job Summary
Pfizer is seeking an experienced Aggregate Report Analyst Manager to lead the preparation of regulatory safety reports and risk management documents. The role involves creating high-quality, compliant aggregate safety reports such as DSURs, PBRERs, RMPs, and safety responses to regulatory authorities. You will collaborate with cross-functional teams to ensure timely, accurate, and regulatory-compliant document submissions that support global drug safety and benefit-risk assessments.
Key Responsibilities
Create and review aggregate safety documents including DSURs, PBRERs, RMPs, and Addendums to Clinical Overviews.
Translate regulatory requirements and corporate policies into compliant safety reports and benefit-risk assessments.
Collaborate with project teams to develop document strategies, resolve information gaps, and ensure accuracy.
Provide oversight to internal or external co-authors for specific documents.
Manage timelines, communicate resource needs, and negotiate document delivery schedules.
Review documents produced by external vendors and assess vendor performance.
Act as a point of contact for all document issues for assigned products.
Identify areas for process improvement and communicate solutions to management.
Build strong collaborations with cross-functional teams, including country-level organizations.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences with 3+ years of relevant medical or pharmaceutical experience (clinical trials, regulatory, pharmacovigilance).
Advanced degree (MD, DVM, PharmD, Master’s/Ph.D.) preferred.
Proven experience in pharmacovigilance, medical writing, or regulatory documentation.
Strong understanding of regulatory guidance on benefit-risk assessments and safety reporting.
Skilled in synthesizing aggregate safety data into concise, high-quality written reports.
Analytical problem-solving ability and familiarity with drug safety concepts.
Excellent communication, time management, and organizational skills.
Perks & Benefits
Opportunity to work with a global leader in healthcare and drug safety.
Collaborative environment with exposure to global regulatory frameworks.
Continuous learning and professional development opportunities.
Competitive compensation and benefits (as per company standards).
Company Description
Pfizer is one of the world’s premier innovative biopharmaceutical companies, dedicated to discovering, developing, and delivering safe, effective medicines. With a strong presence in clinical research, pharmacovigilance, and regulatory sciences, Pfizer is committed to improving global health outcomes.
Work Mode: On-site (Chennai, India)
Call-to-Action
If you are an experienced professional in pharmacovigilance or safety report writing, apply now for the Aggregate Report Analyst Manager position at Pfizer and take your career to the next level.
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