Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes Whether you are creating framework necessary to ensure our evidence is scientifically sound providing unbiased medically necessary expertise or investigating how to close gaps in data our mission is simple Empower healthcare decisions regarding the safe and appropriate use of medicines for patients Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development license application and post-marketing maintenance on behalf of and in conjunction with corresponding project teams These documents include but are not limited to integrated analyses of safety data in support of aggregate reports e g Development Safety Update Reports Periodic Safety Update Reports Period Benefit Risk Evaluation Reports Addendum to Clinical Overviews Recent Drug Application Periodic Adverse Drug Experience Reports Safety Update Reports Canadian Annual Reports etc responses to regulatory queries on safety topics post-marketing safety assessments and Risk Management Plans and relevant documents Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents Assess document requirements gauge document complexity and identify information gaps or other potential issues In collaboration with the relevant project team the author proposes or contributes to strategies to resolve any identified issues Provide oversight for internal or external contractor co-authors when required for a particular project or assignment e g Canadian Annual Report Qualification Requirement i e preferred education experience attributes Education Bache

📌 Manager Aggregate Reports Analyst (Chennai)
🏢 Pfizer
📍 Chennai