Role Overview
Parexel is seeking an experienced Director, Patient Safety Medical Writing to provide functional and operational leadership within its global Patient Safety organization. Available as a fully remote role based in Bengaluru or Hyderabad, India, this senior leadership position oversees medical writing, safety operations, quality initiatives, regulatory compliance, and team development across global pharmacovigilance deliverables.
Core Responsibilities
Operational & Functional Leadership: Lead, mentor, and manage safety medical writing and patient safety teams, directing recruitment, talent development, performance management, and succession planning.
Strategic Planning & Governance: Implement pillar-specific strategies aligned with Parexel's global Patient Safety goals; manage operational plans, resource forecasting, and departmental budgeting.
Global Regulatory Compliance: Ensure strict adherence to global and multi-regional pharmacovigilance regulations including ICH, CIOMS, Good Pharmacovigilance Practices (GVP), and local health authority mandates.
Quality Oversight & Audit Readiness: Oversee standard operating procedures (SOPs), key performance indicators (KPIs), quality metrics, and Corrective and Preventive Actions (CAPA) systems to safeguard patient safety data integrity and audit readiness.
Client & Project Management: Manage sponsor relationships and enterprise client deliverables, ensuring high standards of productivity, compliance, and revenue realization.
Innovation & Workflow Transformation: Spearhead process excellence and digital workflow modernization initiatives, leveraging automation and AI tools to optimize safety writing cycles and operational throughput.
Cross-Functional Collaboration: Partner across safety pillars, Clinical Operations, and Regulatory Affairs while serving as a senior Patient Safety functional representative in audits, client forums, and industry conferences.
Technical & Domain Standards
Comprehensive mastery of clinical safety data, aggregate safety reports (PSUR/PBRER, DSUR), Risk Management Plans (RMP), clinical trial safety narratives, and pharmacovigilance databases.
Integration and optimization of pharmacovigilance technology platforms, CTMS, and electronic Trial Master File (eTMF) environments.
Benefits & Workplace Culture
Fully remote, flexible work arrangement backed by a globally recognized clinical development organization.
Comprehensive rewards structure, leadership development tracks, and robust healthcare and family benefits.
