• Coordinate with Clinical, Regulatory, Safety, DevOps, and Submissions teams
• Review and validate safety data for accuracy, consistency, and regulatory compliance
• Compile aggregate reports using electronic authoring and document management tools
• Manage cross-functional reviews, approvals, and resolution of comments
• Ensure timely submissions to global health authorities (FDA, EMA, etc.)
• Support process improvements, special projects, and UAT activities
• Complete mandatory training under Pfizer Safety Information Management curriculum
Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Healthcare, or related discipline
Experience
• Experience in pharmacovigilance, safety aggregate reporting, clinical research, or pharmaceutical industry
• Exposure to global regulatory submissions preferred
Skills
• Strong knowledge of global safety regulations (ICH, FDA, EMA)
• Proficiency in MS Word, Excel, Adobe Acrobat, ISI Toolbox, SharePoint
• Business Objects knowledge is an added advantage
• Excellent written and verbal communication skills
• Strong coordination, project management, and problem-solving abilities
• High attention to detail and data accuracy
About the Company
Pfizer is a global biopharmaceutical leader committed to discovering, developing, and delivering innovative medicines and vaccines. With a strong focus on science, quality, and patient safety, Pfizer offers dynamic career opportunities and global exposure across drug development, pharmacovigilance, and regulatory operations.