Senior Manager, Process Compliance Review and Analysis in Pune, भारत

Fortrea seeks a Senior Manager to establish and oversee quality processes for pharmacovigilance and safety writing engagements. The role involves driving compliance, process improvement, and audit readiness across assigned projects while serving as the quality expert for clients and delivery teams.

Responsibilities

• Establish and implement quality processes across pharmacovigilance and safety writing engagements
• Oversee quality reviews, metrics, analysis, and corrective actions across assigned projects
• Drive CAPA management and audit readiness; identify quality trends and recommend improvements
• Support internal and regulatory audits; ensure inspection readiness and client compliance during inspections
• Develop SOPs, quality management plans, and provide inputs on training needs and process standardization

Requirements

• Bachelor's, Master's, or PhD in Medicine, Medical Science, Pharmaceutical Science, Nursing, or Life Sciences
• 15+ years in pharmaceutical, biotechnology, or CRO industry focused on pharmacovigilance and safety writing
• Knowledge of GPV regulations and applicable EU and FDA guidelines
• In-depth understanding of single case processing, assessment, and safety writing
• Familiarity with Lean and Six Sigma methodologies
• Proficiency with Microsoft Office applications and system validations