Job Summary
The Director, Patient Safety Intake and Regulatory Submissions plays a pivotal role in ensuring the safety and integrity of products.
Key Responsibilities:
* Oversight of patient safety intake and regulatory submissions processes to guarantee compliance with global regulations and contractual obligations.
* Liaise with health authorities, Alliance Partners, and internal stakeholders to foster collaborative relationships and drive business success.
* Develop and maintain best practices for high-quality and compliant point-of-contact activities, leveraging expert knowledge of tools and systems for data automation, advanced data validation, and analytics.
* Manage vendors and oversee database configuration and assessment of study particulars, ensuring seamless integration and efficient operations.
* Review and creation of metrics to measure intake and reporting compliance, driving continuous improvement and excellence.
* Train and mentor staff on safety information and intake submission processes, promoting knowledge sharing and skill development.
* Serve as subject matter expert for audits and inspections, providing authoritative guidance and support.
Requirements:
* Bachelor's Degree in life sciences or clinical research, or a licensed healthcare professional, required for this position.
* Minimum 12 years of experience in safety and safety reporting, demonstrating expertise and leadership skills.
* Excellent knowledge of Argus and its applications, essential for success in this role.
* Strong written and verbal communication skills, critical for effective collaboration and stakeholder engagement.
* Ability to work independently and prioritize effectively in a matrix team environment, managing multiple tasks and deadlines.
About Us:
Our organization values diversity and inclusion, providing comprehensive benefits and opportunities for growth and development. We are an equal opportunity employer, welcoming applicants from diverse backgrounds.