Parexel
Lead end-to-end signal management activities including detection, validation, evaluation, tracking, and closure Perform and oversee qualitative and quantitative signal analysis across clinical, post-marketing, literature, and regulatory data sources Ensure compliance with global pharmacovigilance regulations and client-specific processes Provide oversight and/or author aggregate safety reports (Periodic Benefit-Risk Evaluation Report (PBRERs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and allied documents) Guide development of Corporate Social Responsibility (CSR) narratives and safety assessments, ensuring scientific rigor and regulatory compliance Ensure effective integration of signal outputs into aggregate reporting and risk management strategies Oversee delivery across signal management and aggregate writing prog...
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Senior Manager, Medical Writing Services
Description
When our values align, there's no limit to what we can achieve.