Director, Patient Safety – Medical Writing

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

✏️ Content Writer

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead and manage the assigned Patient Safety team and function, including recruitment, performance management, career development, and succession planning • Implement pillar-specific strategies aligned with Parexel's global Patient Safety objectives • Contribute to operational plans, budget management, and resource allocation • Maintain compliance with global and local regulations, including ICH, CIOMS, GVP, and multi-region pharmacovigilance requirements • Implement Patient Safety Quality initiatives • Develop, review, and oversee SOPs, metrics, KPIs, audits, CAPA processes, and quality oversight systems • Manage projects and client relationships while ensuring productivity, quality, compliance, revenue, budgeting, and financial monitoring standards • Drive workflow enhancement and process excellence initiatives using automation and AI • Lead cross-functional deployment and optimization of pharmacovigilance systems and digital solutions • Represent Patient Safety in functional forums, projects, and selected external interactions • Coach staff in Patient Safety best practices and quality standards

🎯 Requirements

• Bachelor's degree or equivalent experience in health sciences or a related discipline • Significant experience in pharmacovigilance, drug safety, medical writing, safety operations, project management, or quality management • Proven experience as a team leader within Patient Safety or related fields • Experience in project and client management, including support of audits and inspections • Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes • Strong knowledge of clinical, scientific, and regulatory aspects of drug safety and patient safety • Demonstrated ability in managing teams and supporting quality and compliance initiatives • Effective operational and tactical skills including planning, budgeting, and influencing • Strong communication, negotiation, stakeholder management, organization, and problem-solving skills • Patient-focused mindset and strong attention to detail

🏖️ Benefits

• Flexibility and space to do your best work • Continuous learning opportunities • Ongoing professional education • Participation in regulatory meetings, industry forums, and scientific conferences