Job Description
When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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 programs Manage timelines, resources, budgets, and risks to ensure high-quality, on-time delivery Drive operational excellence, efficiency, and continuous process improvement Managerial Responsibilities Provide overall leadership and strategic direction to teams, ensuring alignment with organizational goals and client expectations Oversee end-to-end delivery, ensuring quality, timeliness, and efficiency across projects Manage resource planning, workload distribution, and budget considerations to optimize productivity Drive performance management, coaching, and development of team members En
