Sr. Director, Safety Operations and Infrastructure

Summary:

Reporting to the VP, Global Patient Safety and Risk Management, the Senior Director, Safety Operations and Infrastructure is accountable for developing and overseeing all pharmacovigilance operational processes and activities, in-house and with vendors.  The Senior Director will lead the development, implementation, and continuous improvement of technical safety infrastructure for Aimmune to support both clinical trial and post-marketing safety

Specific Responsibilities:

• Accountable for identification, initiation, development and implementation of PV process improvements, tools, systems and procedures to ensure quality and consistency in safety operations, data output, studies and programs.
• Responsible for implementing and maintaining safety database, safety data standards, safety data quality, case processing and follow-up with vendor support
• Responsible for working with the safety medical team to implement and support appropriate analysis tools for safety data from study and post-marketed environments
• Act as project manager for aggregate reports and assure appropriate, timely and accurate data outputs from the safety database
• Lead the budget planning for the safety operations function and report on ongoing budget initiatives
• Serve as subject matter expert (SME) for audits and inspections as well as ensure preparedness for all safety-related documentation to be filed properly for inspection
• Build and lead a team of safety operations specialists to meet the needs of the growing organization

Qualifications / Requirements:

• Advanced degree in life sciences, nursing, pharmacy or medicine; PhD, PharmD, BsN
• 10+ years  of experience in global pharmacovigilance operations for a biotechnology or pharmaceutical company in both clinical trial and post marketing environments.
• 6 years or more years of functional management experience overseeing PV staff
• A working understanding of drug safety databases (Argus), safety coding dictionaries, technical requirements, and analytic tools

Preferred Experience, Special Skills, Knowledge:

• Thorough understanding of the drug development process
• Thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, GPV and GCP
• Experience in ICSR management and reporting, aggregate reporting
• Vendor management and oversight experience
• Effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
• Excellent people management skills