Director, Patient Safety – Medical Writing

This is a fully remote position, open to applicants in India.

📋 Description

• Lead and oversee the designated Patient Safety team and function, which includes recruitment, performance management, career development, and succession planning.

• Execute pillar-specific strategies that align with Parexel's global objectives in Patient Safety.

• Play a role in the formulation of operational plans, management of budgets, and allocation of resources.

• Ensure adherence to both global and local regulations, encompassing ICH, CIOMS, GVP, and multi-region pharmacovigilance standards.

• Roll out Patient Safety Quality initiatives.

• Develop, assess, and supervise SOPs, metrics, KPIs, audits, CAPA processes, and quality oversight mechanisms.

• Manage projects and client relationships while upholding productivity, quality, compliance, revenue, budgeting, and financial monitoring benchmarks.

• Propel workflow enhancements and process excellence initiatives by leveraging automation and AI technologies.

• Lead the cross-functional deployment and optimization of pharmacovigilance systems and digital solutions.

• Represent the Patient Safety function in various forums, projects, and selected external engagements.

• Mentor staff on best practices and quality standards in Patient Safety.

⛳️ Requirements

• Bachelor's degree or equivalent experience in health sciences or a related field.

• Extensive experience in pharmacovigilance, drug safety, medical writing, safety operations, project management, or quality management.

• Proven track record as a team leader in Patient Safety or similar domains.

• Experience in managing projects and client relationships, including participation in audits and inspections.

• Familiarity with ICH-GCP, regulatory standards, and clinical trial procedures.

• Strong understanding of the clinical, scientific, and regulatory aspects of drug and patient safety.

• Demonstrated capability in team management and support of quality and compliance initiatives.

• Effective operational and tactical skills, including planning, budgeting, and influence.

• Excellent communication, negotiation, stakeholder management, organizational, and problem-solving abilities.

• A patient-centered mindset with a keen attention to detail.

🏝️ Benefits

• Flexibility and the opportunity to perform at your best.

• Continuous learning opportunities.

• Ongoing professional education.

• Participation in regulatory meetings, industry forums, and scientific conferences.