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🥝 Senior Manager, Medical Writing Services
Parexel | Gachibowli, India | Posted June 24, 2026
Job Description
When our values align, there's no limit to what we can achieve.
Lead end-to-end signal management activities including detection, validation, evaluation, tracking, and closurePerform and oversee qualitative and quantitative signal analysis across clinical, post-marketing, literature, and regulatory data sourcesEnsure compliance with global pharmacovigilance regulations and client-specific processesProvide 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 complianceEnsure effective integration of signal outputs into aggregate reporting and risk management strategiesOversee delivery across signal management and aggregate writing prog...