Executive Director – Safety Operations

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

📋 Description

• Ensure the comprehensive execution, quality, and ongoing enhancement of global safety operations activities.

• Supervise the efficient collection, processing, evaluation, and reporting of Individual Case Safety Reports (ICSRs) in alignment with global standards.

• Manage safety operations related to clinical trials, in addition to pharmacovigilance (PV) activities in China.

• Oversee safety systems and reporting functions.

• Proactively shape the operational technology strategy of Global Pharmacovigilance Services (GPS).

• Deliver extensive and profound technical expertise.

• Assist in and contribute to the internal development of the GPS department.

• Collaborate across functions to fulfill pharmacovigilance responsibilities.

• Develop projections for resource requirements in safety operations.

• Recruit, retain, train, and mentor staff within safety operations.

• Participate in audits and inspections.

• Track the communication of drug safety information and guarantee timely dissemination.

⛳️ Requirements

• MD, PharmD, RN with an advanced degree or an equivalent international qualification, or a comparable mix of relevant education and professional experience.

• In-depth knowledge of global safety regulatory standards.

• A minimum of fifteen (15) years of relevant experience, including training.

• At least ten (10) years of experience in drug safety.

• Expertise in processing safety reports and managing operational systems.

• Proficiency in signal detection, statistical methods, and trial methodologies and outputs.

• Prior management experience is necessary.

• Experience in process and systems management is preferred.

• Clinical experience is an advantage.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness