10 Aug
|
Parexel
|
Hyderabad
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 deve
📌 Senior Manager, Medical Writing Services (Hyderabad)
🏢 Parexel
📍 Hyderabad