Director, Drug Safety Operations

About Us

About the Role

The Director, Drug Safety Operations will have a significant impact across our three programs and future pipeline.

Reporting to the VP of Drug Safety and Pharmacovigilance, you will be responsible for oversight of safety operations activities with vendors and partners, including implementing safety reporting processes, monitoring compliance with internal standard operating procedures, overseeing adverse event case management, oversight of the drug safety database, providing support to study teams and projects. You  will work closely with our internal teams and meet with world-wide representatives weekly in support of our trials. You must have global experience as a safety operations lead in order to be successful in this role.

This is a great opportunity to join an early stage clinical start up and support our pipeline through commercialization efforts. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Serve as drug safety operations lead on safety reporting processes according to study protocols
• Lead and manage the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities
• Review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up and timely submission of expedited safety reports
• Establish and maintain Safety Management Plans
• Provide sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management Plans
• Oversee safety case workflow (case receipt through submission) between safety vendor(s) and Dianthus
• Serve as drug safety representative for the operational aspects of the SAE reconciliation process and aggregate safety reports/line listings generation
• Develop and maintain of the safety database in collaboration with safety vendor
• Participate in establishing and maintaining Data Exchange Agreements as applicable
• Develop and maintain drug safety and pharmacovigilance SOPs, guidelines, forms guidelines to ensure compliance with all applicable regulatory requirements and industry best practices
• Develop and monitor performance (metrics, other reports) of the safety vendor and the quality of individual safety cases and aggregate reports and line listing; provide ongoing feedback and training if warranted
• Monitor key performance indicators of case processing and present findings to the head of drug safety and pharmacovigilance
• Responsible for the operational aspects of safety inspection readiness activities and actively participates in these inspections
• Stays current with international drug safety and pharmacovigilance requirements and guidelines
• Other duties as assigned

Experience

• MD, PharmD, or RN with minimum 5+ years of drug safety operations experience
• Prior experience overseeing and managing safety vendor(s) a must
• Strong proficiency with safety databases and safety coding dictionaries
• Competent knowledge and understanding of international safety reporting
• Knowledge of and ability to apply pre- and post-marketing drug safety standards
• Excellent communications skills (oral and written)
• Excellent interpersonal skills and ability to work effectively as part of a team(s)
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency